BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NO FILAFORM INSERTER ENDOSCOPIC CAP STONE EXTRACTOR

    MDR report key: 5079 · Received June 11, 1993

    Report

    Report Number
    5079
    Event Type
    Malfunction
    Date Received
    June 11, 1993
    Date of Event
    April 21, 1993
    Report Date
    April 28, 1993
    Manufacturer
    COOK, INC.
    Product Code
    FFL
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    APRIL 21, 1993, APPROX. 1600 HOURS, LAPAROSCOPIC CHOLECYSTECTOMY UNDERWAY WHEN A COMMON DUCT STONE IMPACTED IN THE AMPULLA OF VATER. BASKET STONE EXTRACTOR PASSED THROUGH CHOLEDOCHOSCOPE AND STONE WAS GRASPED. UNABLE TO FREE BASKET AS THERE APPEARED TO BE TRACTION ON THE CATHETER. NUMEROUS ATTEMPTS TO OPEN AND CLOSE AND RELEASE THE STONE WERE CARRIED OUT BUT STILL UNABLE TO GET RELEASE DEVICE TO WORK PROPERLY. GENTLE TRACTION UNSUCCESSFUL. MANIPULATIOLN UNSUCCESSFUL. CHOLEDOCHOSCOPE WAS REMOVED BY TAKING THE CLOSING AND OPENING DEVICE OFF THE END OF THE BASKET DEVICE. BASKET STILL WOULD NOT RELEASE. ANOTHER PULL ON THE BASKET RESULTED IN A SUDDEN RELEASE AND BASKET DEVICE WAS RETRACTED BUT THE ACTUAL WIRE BASKET PORTION WAS NOT VISIBLE. CHOLANGIOGRAM REVEALED BASKET IMPACTED IN THE AMPULLA AND STONE IN QUESTION ASSUMED TO HAVE BEEN PUSHED FORWARD. PROCEDURE COMPLETED (CHOLECYSTECTOMY). GASTROENTEROLOGIST IMMEDIATELY PERFORMED GASTRODUODENOSCOPY. AT THE SECOND PORTION OF THE DUODENUM, AT THE MAJOR AMPULLA, THE BASKET WAS PROTRUDING. IT WAS REMEOVED WITH BIOPSY FORCEPS VIA THE ENDOSCOPY THROUGH THE MOUTH, WITHOUT TRAUMA TO THE PATIENT. NO KNOWN PATIENT INJURY EXCEPT BEING SUBJECT TO A SECOND UNPLANNED PROCEDURE DUE TO WHAT SURGEON DESCRIBES AS A FRACTURE OF THE BASKETDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: TELEMETRY FAILURE, NONE OR UNKNOWN, NONE OR UNKNOWN, NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NO FILAFORM INSERTER ENDOSCOPIC CAP STONE EXTRACTOR 4 WIRE, 115 CM, 3FR FLAT WIRE STONE EXTRACTOR FFL COOK, INC. 0633515

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other