EPIX LAPAROSCOPIC GRASPER
Received Feb 23, 2026
Report 2027111-2026-00394 · MDR key 24423446
Device
Generic name
Laparoscopic Accessories, Gynecologic
Manufacturer
Applied Medical ResourcesModel number
UNKCatalog number
UNK
Lot number
UNK
Product problems
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. AS THE EVENT UNIT WAS NOT RETURNED, TESTING TO IDENTIFY POTENTIAL CONTRIBUTING FACTORS COULD NOT BE PERFORMED. THE DETAILS SURROUNDING THE EVENT WERE REVIEWED AND THE ROOT CAUSE OF THE EVENT IS UNABLE TO BE DETERMINED. APPLIED MEDICAL HAS PERFORMED A HISTORICAL TREND ANALYSIS AND REVIEW OF PRODUCTION RECORDS AND NO RELEVANT DOCUMENTATION WAS IDENTIFIED.
Description of Event or Problem
EVENT DATE UNKNOWN. PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: DURING TREATMENT, PAD CAME OFF THE GRASPER. WERE UNSURE IF IT WAS LEFT INSIDE THE PATIENT, IF IT WAS IDENTIFIABLE VIA X-RAY. INTERVENTION: UNK. PATIENT STATUS: UNK.
Additional Manufacturer Narrative
THE EVENT UNIT IS NOT BEING RETURNED FOR EVALUATION, AND NO LOT NUMBER HAS BEEN PROVIDED TO APPLIED MEDICAL. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
EVENT DATE UNKNOWN PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: DURING TREATMENT, PAD CAME OFF THE GRASPER. WERE UNSURE IF IT WAS LEFT INSIDE THE PATIENT, IF IT WAS IDENTIFIABLE VIA X-RAY. INTERVENTION: UNK, PATIENT STATUS: UNK.