BEUDAMED
    FDA Adverse Event Summary report: N

    3005075853-2010-05718

    MDR report key: 1855101 · Received October 6, 2010

    Report

    Report Number
    3005075853-2010-05718
    Date Received
    October 6, 2010
    Product Code
    GCJ
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING INFORMATION WAS OBTAINED DURING A CONFERENCE CALL WITH THE EES SALES REP, CQ, MARKETING, MANUFACTURING ENGINEER, AND QUALITY ENGINEER: THE REP INDICATED HE WAS IN THIS CASE WHEN THE EVENT OCCURRED. HE DID NOT OBSERVE ANY USE RELATED ISSUES. NO FURTHER QUALITY ISSUES WITH THE POUCH DEVICE HAVE BEEN REPORTED TO THE REP SINCE THIS TIME PERIOD. A CONFERENCE CALL WAS SCHEDULED WITH THE EES TEAM AND A SURGEON AT THIS FACILITY TO DISCUSS THE USE OF THE POUCH DEVICE AT THIS ACCOUNT. PER THE REP, THE SURGEON WAS CALLED INTO AN EMERGENCY SURGERY AND THE CALL WAS CANCELLED. THE SURGEON INDICATED HE WOULD REACH OUT TO EES IF THE CALL WAS STILL NECESSARY. TO DATE, THE SURGEON HAS NOT REQUESTED A CALL.

    Additional Manufacturer Narrative · 1

    (B)(4). BAG. THE ANALYSIS RESULTS OF THE POUCH FOUND THAT ONLY THE BAG WITH THE SUTURE CUT WERE RECEIVED FOR ANALYSIS. DURING EVALUATION, THE BAG WAS NOTED TO BE TORN AT THE BOTTOM END (NOT AT THE SEAMS). THE TORN PORTION WAS NOTED TO BE STRETCHED. EACH DEVICE IS 100% VISUALLY INSPECTED AT TWO DIFFERENT ASSEMBLY OPERATIONS PRIOR TO SHIPMENT AND DAMAGE OF THIS MAGNITUDE WOULD HAVE BEEN DETECTED DURING THIS INSPECTION. HOWEVER, A POTENTIAL CAUSE OF THE TORN BAG IS AN ATTEMPT TO REMOVE THE BAG WITH A SPECIMEN THROUGH THE TROCAR OR TO FORCE THE BAG THROUGH THE ACCESS SITE, AS THIS MAY LEAD TO BAG RUPTURE AND SPILLAGE OF CONTENTS. THE FOLLOWING OPTIONS ARE RECOMMENDED IN ORDER TO AVOID THIS KIND OF ISSUE: REMOVE THE INSTRUMENT, SPECIMEN BAG, AND TROCAR TOGETHER FORM THE ACCESS SITE (DO NOT PULL THE SLIP KNOT). REMOVE THE INSTRUMENT FROM THE TROCAR, FOLLOWING BY THE SPECIMEN BAG WITH THE TROCAR. REMOVE THE INSTRUMENT, TROCAR AND SPECIMEN BAG SEPARATELY FROM THE ACCESS SITE. IF THE BAG WITH THE SPECIMEN CANNOT BE REMOVED THROUGH THE ACCESS SITE, CAREFULLY ENLARGE THE ACCESS SITE TO FACILITATE EASY BAG REMOVAL. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE BOTTOM OF THE BAG BLEW OUT WHILE PULLING THE SPECIMEN THROUGH THE TROCAR INCISION. NONE OF THE CONTENTS FELL INTO THE PATIENT. A COUPLE OF CLAMPS WERE USED TO COMPLETELY REMOVE THE SPECIMEN. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GCJ

    Patients

    Seq Age Sex Outcome Treatment
    1