BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOCEPS POLYPECTOMY SNARE, OVAL, LARGE

    MDR report key: 1526884 · Received November 10, 2009

    Report

    Report Number
    1056129-2009-00001
    Event Type
    Injury
    Date Received
    November 10, 2009
    Date of Event
    October 14, 2009
    Report Date
    November 10, 2009
    Manufacturer
    ENDO-THERAPEUTICS, INC.
    Product Code
    FDI
    PMA / PMN Number
    K800965
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE RETURNED WAS ONLY A HANDLE WITH 4 INCHES OF SHAFT AND CONTROL WIRE. A CONTINUITY CHECK WAS PERFORMED BETWEEN THE HOT PLUG CLIP AND END OF CUT WIRE, WHICH PASSED AS NORMAL. THIS MEANS THAT THE CONNECTION IN THE HANDLE BETWEEN THE HOT PLUG CLIP AND PUSH ROD AND BETWEEN THE PUSH ROD AND CONTROL WIRE WERE IN GOOD WORKING CONDITION. IT WAS OBSERVED THAT THE TEFLON SHAFT NEAR THE TIP OF THE HANDLE WAS TWISTED. THIS HAS BEEN OBSERVED ON RETURNED DEVICES IN THE PAST AND WAS DETERMINED TO BE THAT EXCESSIVE FORCE WAS APPLIED TO THE HANDLE BY THE USER. THIS EXCESSIVE FORCE COULD HAVE LED TO A FAILURE AT THE SNARE TIP BUT SINCE THE REMAINED OF THE DEVICE WAS NOT RETURNED, A FULL AND COMPLETE EVALUATION COULD NOT BE COMPLETED. THEREFORE, THE EXACT ROOT CAUSE OF WHY THE DEVICE DID NOT CAUTERIZE CANNOT BE DETERMINED. ALL SNARE DEVICES ARE 100% INSPECTED FOR PROPER OPERATION, INCLUDING ELECTRICAL CONTINUITY BETWEEN THE HOT PLUG CLIP AND SNARE TIP PRIOR TO PACKAGING, AND ARE SHIPPED IN A FULLY-FUNCTIONAL CONDITION. ETI PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS FOR LOT NUMBER 57326. THIS REVIEW SHOWED THAT ALL INSPECTION STEPS AND OPERATIONS WERE COMPLETED TO REQUIREMENTS WITHOUT EXCEPTION FOR ALL DEVICES. THE EXACT ROOT CAUSE OF WHY THE SNARE DEVICE DID NOT CAUTERIZE CANNOT BE DETERMINED DUE TO THE FACT THAT THE ENTIRE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE PHYSICIAN HAD SNARED A LARGE POLYP WITH A POLYPECTOMY SNARE. WHEN HE TRIED TO CAUTERIZE THE POLYP, IT FAILED. THE GENERATOR WAS CHANGED AND IT FAILED AGAIN. SO, THE PHYSICIAN COULD NOT REMOVE THE POLYP, NOR RELEASE IT. THE PHYSICIAN THEN CUT THE HANDLE OFF OF THE SNARE AND REMOVED THE SCOPE, LEAVING THE SNARE IN PLACE. HE THEN REENTERED WITH THE SCOPE AND ATTEMPTED TO SNARE THE POLYP WITH A SECOND SNARE, BUT WAS UNSUCCESSFUL. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL VIA 911 AND WAS SENT TO SURGERY. IT WAS DETERMINED THAT HE WAS CANCEROUS. A RIGHT HEMICOLECTOMY WAS PERFORMED AND THE SNARE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOCEPS POLYPECTOMY SNARE, OVAL, LARGE SNARE FDI ENDO-THERAPEUTICS, INC. DSO-009 57326

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention