BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CUTTING LOOP

    MDR report key: 7022906 · Received November 10, 2017

    Report

    Report Number
    1820334-2017-04179
    Event Type
    Injury
    Date Received
    November 10, 2017
    Date of Event
    October 12, 2017
    Report Date
    March 6, 2018
    Manufacturer
    COOK INC
    Product Code
    GEI
    PMA / PMN Number
    K935874
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION: A VISUAL EXAMINATION AND SUPPLIER EVALUATION HAS BEEN PERFORMED. A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, QUALITY CONTROL DATA AND DEVICE SPECIFICATIONS WAS ALSO CONDUCTED. ONE PLASTIC TUBE CONTAINING A CL-2412-12-OL WAS RETURNED. THE LOOP OF ONE THE PRONGS OF THE CUTTING LOOP HAS BEEN SEVERED AND COMPLETELY SEPARATED. THE LOOP WAS RETURNED LOOSE INSIDE THE PLASTIC TUBE. THE PRONGS WERE CHARRED AND HAD A BURNT APPEARANCE ON THE DISTAL TIP. THIS DEVICE WAS RETURNED TO THE SUPPLIER FOR INVESTIGATION. THE SUPPLIER PERFORMED A DEVICE HISTORY RECORD REVIEW. THIS LOT HAD (B)(4) ASSOCIATED NON-CONFORMANCES. THERE WERE (B)(4) PIECES REWORKED FOR CRITICAL LENGTH. THIS ORDER WAS 100% INSPECTED FOR CRACKS/BREAKS IN TUNGSTEN (PER STANDARD PROCEDURE) RESULTING IN (B)(4) PIECES SCRAPPED. VISUAL INSPECTION OF THE SAMPLE BY THE SUPPLIER NOTED THE ELECTRODE HAS NO LOOP ATTACHED. CHARRING IS PRESENT ON THE ENDS OF THE LEGS OF THE ELECTRODE. A REVIEW OF PREVIOUS CUSTOMER COMPLAINTS NOTED 1 PREVIOUS COMPLAINT IN 2017 FOR A DIFFERENT SHOP ORDER AND A DIFFERENT TUNGSTEN LOT. AN EXACT CONCLUSION COULD NOT BE REACHED. NO MANUFACTURING DEFECTS NOTED. BASED ON THE EVIDENCE PRESENTED BY THE SAMPLE AND THE INFORMATION PROVIDED BY THE SUPPORTING DOCUMENTATION AN EXACT CONCLUSION COULD NOT BE DRAWN. THE INSTRUCTIONS FOR USE CONTAINS THE FOLLOWING WARNINGS AND PRECAUTIONS: ¿ DO NOT BEND OR CHANGE ANGLE OR SHAPE OF THE DISTAL END. TO DO SO MAY CAUSE POOR FUNCTION, DAMAGE TO THE RESECTOSCOPE AND INJURY TO THE PHYSICIAN AND/OR THE PATIENT. ¿ CARE SHOULD BE TAKEN TO AVOID SEVERE IMPACTS, SIDE STRESSES OR BENDS AT SHARP ANGLES. THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT OBSERVE ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. BASED ON THE INVESTIGATION EVALUATION, THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY; DEVICE INTEGRITY PRIOR TO SHIPPING. BASED ON THE PROVIDED INFORMATION, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE AREA REPRESENTATIVE REPORTED THAT ON (B)(6) 2017, A (B)(6) MALE PATIENT UNDERWENT A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP). DURING THE PROCEDURE WHILE USING THE COOK CUTTING LOOP, ONE OF THE LOOPS CAME OFF AND HAD TO BE EXTRACTED FROM THE PATIENT. THE LOOP WAS RETRIEVED WITH A CYSTOSCOPE AND GRASPERS DURING THE TURP PROCEDURE. NO UNINTENDED PORTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT BECAUSE OF THIS REPORTED ISSUE. ON OCTOBER 30, 2017, VOLUNTARY MEDWATCH REPORT MW5072903 WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798469 COOK CUTTING LOOP GEI UNIT, ELECTROSURGICAL AND ACCESSORIES GEI COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention