CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE

Additional Manufacturer Narrative

INVESTIGATION EVALUATION: THE PRODUCT SAID TO BE INVOLVED WAS RETURNED IN AN OPEN POUCH FROM THE LOT NUMBER PROVIDED IN THE REPORT. THE LABEL MATCHES THE PRODUCT RETURNED. OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. THE DEVICE WAS RETURNED WITH ONE CUP ASSEMBLY COMPLETELY DETACHED. THE OTHER CUP ASSEMBLY WAS STILL ATTACHED BUT HAD A BROKEN LINK WIRE. THE DEVICE WAS SENT TO THE SUPPLIER FOR FURTHER EVALUATION AND THE FOLLOWING WAS PROVIDED, "VISUAL EVALUATION OF THE RETURNED DEVICE OBSERVED THAT THE TIP ASSEMBLY HAD ONE CUP MISSING. DUE TO THE CONDITION OF THE DEVICE, A FUNCTIONALITY EVALUATION WAS NOT PERFORMED. UPON RECEIPT OF THE RETURNED DEVICE, THE COMPONENTS WERE DISASSEMBLED. DEVICE COMPONENTS SHOWED NO INTERNAL SIGNS OF DAMAGE. WHEN THE TIP ASSEMBLY WAS DISASSEMBLED, THE PIVOT PIN WAS MISSING SWAGE AFTER THE CRIMPING PROCESS. THE BATCH RECORD WAS REVIEWED AND DID NOT REVEAL ANY NONCONFORMANCES DURING ASSEMBLY, TO INCLUDE MATERIAL COMPONENTS, ASSEMBLY LINE EQUIPMENT AND IN PROCESS CHECKS. IT WAS CONCLUDED THAT THE DETACHED CUP WAS A RESULT OF INADEQUATE CRIMP AND HUMAN ERROR WAS DETERMINED TO BE THE ROOT CAUSE." THE DEVICE HISTORY RECORDS FOR (B)(4) WAS MANUFACTURED JANUARY 2024 AND (B)(4) WERE MANUFACTURED NOVEMBER 2023. THERE WERE NO RELEVANT DEFECTS NOTED IN THE MANUFACTURING/FQC CHECKLISTS. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSION: OUR LABORATORY EVALUATION OF THE DEVICE CONFIRMED THE COMPLAINT. THE SUPPLIER PROVIDED THE FOLLOWING, "AWARENESS TRAINING WILL BE CONDUCTED WITH THE PERSONNEL INVOLVED. THE COMPLAINT WAS CONFIRMED AND IT WAS DETERMINED THAT HUMAN ERROR WAS THE ASSIGNABLE CAUSE OF THE NONCONFORMING DEVICE. A REVIEW OF THE RISK ASSESSMENT BASED ON DFMEA-197 COOK CAPTURA PRO¿ COLD BIOPSY FORCEPS STATES THAT IF A DEVICE HAS A RECOGNIZABLE DEFECT PRIOR TO THE ONSET OF PROCEDURE, THE POTENTIAL FOR INJURY IS UNLIKELY AND WOULD CAUSE AN INSIGNIFICANT DELAY IN PROCEDURE." PRIOR TO DISTRIBUTION, ALL CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED AND THIS REPRESENTS AN ISOLATED OCCURRENCE. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED REMOTE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

Description of Event or Problem

IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK CAPTURA PRO¿ BIOPSY FORCEPS WITH SPIKE. IT WAS INITIALLY REPORTED THAT IT WAS BROKEN RIGHT OUT OF THE PACKAGE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RETURNED FOR EVALUATION AND RECEIVED ON 20MAR2024 AND THE CUP HAD DETACHED. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.