CLIP, IMPLANTABLE

Description of Event or Problem

This report is being filed after the review of a clinical evaluation report (CER) from a related research activity database (DRRA) for patients undergoing unknown procedure. The reported complication as per ICD 9 & 10 categorization experienced by the following with corresponding intervention: Evaluation of Performance and Safety Outcomes of LIGACLIP¿ and LIGAMAX¿ 5 Multiple Clip Appliers and LIGACLIP¿ Extra Ligating Clips.Outcome Description Perioperative leakage. Rules Defined as the presence of an ICD-10-CM diagnosis code (primary or secondary) for perioperative wound dehiscence or air leak during the index episode of care (see Appendix 1). Appendix 1. ICD-10-CM Diagnosis Codes for Perioperative Leakage (Wound Dehiscence & Air Leak) Code Code Description T81.30% Disruption of wound, unspecified T81.320% Disruption or dehiscence of gastrointestinal tract anastomosis, repair, or closure T81.328% Disruption or dehiscence of closure of other specified internal operation (surgical) wound T81.329% Deep disruption or dehiscence of operation wound, unspecified J93.82 Other air leak J93.83 Other pneumothorax J93.9 Pneumothorax, unspecifiedCount LIGACLIP MCA: 2,188. LIGACLIP Endoscopic Rotating MCA: 473. LIGAMAX 5 Endoscopic MCA: 638. LIGACLIP Extra Ligating Clips: 567.Outcome DescriptionPerioperative bleeding.RulesDefined as the presence of an ICD-10-CM diagnosis code (primary or secondary) for perioperative bleeding during the index the episode of care (see Appendix 2).Appendix 2. ICD-10-CM Diagnosis Codes for Perioperative Bleeding Code Code Description. D78.01 Intraoperative hemorrhage and hematoma of the spleen complicating a procedure on the spleen. D78.21 Postprocedural hemorrhage of the spleen following a procedure on the spleen. D78.31 Postprocedural hematoma of the spleen following a procedure on the spleen. E36.01 Intraoperative hemorrhage and hematoma of an endocrine system organ or structure complicating an endocrine system procedure. E89.810 Postprocedural hemorrhage of an endocrine system organ or structure following an endocrine system procedure. E89.820 Postprocedural hematoma of an endocrine system organ or structure following an endocrine system procedure. I97.411 Intraoperative hemorrhage and hematoma of a circulatory system organ or structure complicating a cardiac bypass.I97.418 Intraoperative hemorrhage and hematoma of a circulatory system organ or structure complicating other circulatory system procedure. I97.611 Postprocedural hemorrhage of a circulatory system organ or structure following cardiac bypass. I97.618 Postprocedural hemorrhage of a circulatory system organ or structure following other circulatory system procedure. I97.631 Postprocedural hematoma of a circulatory system organ or structure following cardiac bypass.I97.638 Postprocedural hematoma of a circulatory system organ or structure following other circulatory system procedure. K91.61 Intraoperative hemorrhage and hematoma of a digestive system organ or structure complicating a digestive system procedure. K91.840 Postprocedural hemorrhage of a digestive system organ or structure following a digestive system procedure.K91.870 Postprocedural hematoma of a digestive system organ or structure following a digestive system procedure.M96.811 Intraoperative hemorrhage and hematoma of a musculoskeletal structure complicating other procedure. M96.831 Postprocedural hemorrhage of a musculoskeletal structure following other procedure. M96.841 Postprocedural hematoma of a musculoskeletal structure following other procedure. J95.61 Intraoperative hemorrhage and hematoma of a respiratory system organ or structure complicating a respiratory system procedure. J95.830 Postprocedural hemorrhage of a respiratory system organ or structure following a respiratory system procedure. J95.860 Postprocedural hematoma of a respiratory system organ or structure following a respiratory system procedure. N99.61 Intraoperative hemorrhage and hematoma of a genitourinary system organ or structure complicating a genitourinary system procedure. N99.820 Postprocedural hemorrhage of a genitourinary system organ or structure following a genitourinary system procedure.N99.840 Postprocedural hematoma of a genitourinary system organ or structure following a genitourinary system procedure.Count LIGACLIP MCA: 1,456. LIGACLIP Endoscopic Rotating MCA: 324.LIGAMAX 5 Endoscopic MCA: 606. LIGACLIP Extra Ligating Clips: 346.Outcome Description Surgical injury RulesDefined as the presence of an ICD-10-CM diagnosis code (primary or secondary) for surgical injury during the index episode of care (see Appendix 3).Appendix 3. ICD-10-CM Diagnosis Codes for Surgical Injury Code Code Description D78.11 Accidental puncture and laceration of the spleen during a procedure on the spleen E36.11 Accidental puncture and laceration of an endocrine system organ or structure during an endocrine system procedure I97.51 Accidental puncture and laceration of a circulatory system organ or structure during a circulatory system procedure K91.71 Accidental puncture and laceration of a digestive system organ or structure during a digestive system procedure M96.821 Accidental puncture and laceration of a musculoskeletal structure during other procedure J95.71 Accidental puncture and laceration of a respiratory system organ or structure during a respiratory system procedure N99.71 Accidental puncture and laceration of a genitourinary system organ or structure during a genitourinary system procedure Count LIGACLIP MCA: 595 LIGACLIP Endoscopic Rotating MCA: 255 LIGAMAX 5 Endoscopic MCA: 476 LIGACLIP Extra Ligating Clips: 147This is for Ethicon. A copy of the clinical evaluation form is being submitted with this regulatory report.

Additional Manufacturer Narrative

PC-002207322Date Sent: 7/23/2026B3: Exact event date UNK, entered 1/1/2026 as only the year was provided.D4: Batch # UNKD4: UDI: As the catalog/model number was not provided, the (01)GTIN is not available.An Analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product Identification number was not provided to complete the evaluation.This report is being submitted pursuant to the provisions of 21 CFR, Part 803. This report may be based on information which has not been investigated or verified prior to the required reporting date. This report does not reflect a conclusion by Ethicon, or its employees that the report constitutes an admission that the product, Ethicon, or its employees caused or contributed to the potential event described in this report. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.