BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO POUCH WITH MEMORY WIRE 5X7"

    MDR report key: 11831877 · Received May 17, 2021

    Report

    Report Number
    3007216334-2021-00217
    Event Type
    Malfunction
    Date Received
    May 17, 2021
    Date of Event
    April 12, 2021
    Report Date
    May 17, 2021
    Manufacturer
    UNIMAX MEDICAL SYSTEMS INC
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    VOLUNTARY DISTRIBUTOR REPORT NARRATIVE: THE MANUFACTURER, UNIMAX MEDICAL SYSTEMS INC., IS RESPONSIBLE FOR PERFORMING EVALUATION, INVESTIGATION AND ANY REMEDIAL ACTIONS RELATED TO THIS REPORTED DEVICE ISSUE PER AGREEMENT WITH CONMED CORPORATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    VOLUNTARY DISTRIBUTOR REPORT. CONMED (B)(4) RECEIVED NOTIFICATION OF REPORTED ISSUES WITH A SB857 ENDO POUCH WITH MEMORY WIRE 5X7", LOT 8251904094, THAT (B)(6) HOSPITAL RECENTLY EXPERIENCED ON (B)(6) 2021. INFORMATION RECEIVED INDICATES DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE FOREIGN MATERIAL WAS DETACHED FROM THE BAG AND DROPPED INTO THE PATIENT BODY DURING THE OPERATION. THE MATERIAL WAS RETRIEVED FROM THE BODY AND WILL BE RETURNED TO THE MANUFACTURE WITH THE DEVICE. THE MATERIAL LOOKED CLEAR AND SMALL BALL AND THE DETACHED MATERIAL WAS RETRIEVED BY FORCEPS. IT IS INDICATED THERE WAS NO IMPACT OR INJURY TO THE PATIENT, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING AN ALTERNATE DEVICE. ADDITIONAL INFORMATION OBTAINED NOTES THE DEVICE WAS RETRIEVED BY THE FORCEPS. NO OTHER INCIDENT CLARIFICATION WAS MADE AVAILABLE. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE AS ALTHOUGH REMOVED, THE PIECE DID FALL INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728962 ENDO POUCH WITH MEMORY WIRE 5X7" LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ UNIMAX MEDICAL SYSTEMS INC 8251904094

    Patients

    Seq Age Sex Outcome Treatment
    1