BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUSH BUTTON PENCIL, EXT.STD. BLADE

    MDR report key: 8520513 · Received April 16, 2019

    Report

    Report Number
    3007305485-2019-00129
    Event Type
    Malfunction
    Date Received
    April 16, 2019
    Report Date
    June 12, 2019
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT
    Product Code
    GEI
    PMA / PMN Number
    K791137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONFIRMED. TWO DEVICES WERE RECEIVED IN UNOPENED ORIGINAL PACKAGING. REPORTED CATALOG WAS VERIFIED. LOT NUMBER WAS VERIFIED. TWO DEVICES WERE SAMPLED FOR INSPECTION. THE SAMPLED DEVICES WERE VISUALLY INSPECTED WITHOUT THE USE OF MAGNIFICATION, FOR A MINIMUM OF (10) SECONDS, AT A DISTANCE OF (12) TO (18) INCHES. RESULTS: (1) NO OBV IOUS DEFECTS AND (1) DEFECT(S) FOUND: THE DEVICE WAS DYE LEAK TESTED, WHICH INDICATED THAT THE PACKAGING HAD AN INSUFFICIENT HEAT SEAL. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WERE FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE WITHIN THE PAST TWO YEARS. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN 79 COMPLAINTS REGARDING (B)(4) DEVICES FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THE SAME TIME FRAME (B)(4) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING; THESE DEVICES SHOULD NEVER BE USED WHEN: THERE IS VISIBLE EVIDENCE OF DAMAGE TO THE EXTERIOR OF THE DEVICES SUCH AS CRACKED, OR DAMAGED PLASTIC OR CONNECTOR DAMAGE AND THESE DEVICES FAIL THE INSPECTION DESCRIBED HEREIN. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE IS BEING RETURNED TO CONMED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THE DISTRIBUTOR IN (B)(4) REJECTED 138114A, PUSH BUTTON PENCIL, EXT, STD BLADE, DUE TO AN "INSUFFICIENT HEAT SEAL". IN THIS INSTANCE, THERE WAS NO PATIENT INVOLVEMENT AS THE PACKAGING ANOMALY WAS DISCOVERED DURING INCOMING INSPECTION PRIOR TO DISTRIBUTION TO AN END-USER. THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313734 PUSH BUTTON PENCIL, EXT.STD. BLADE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONSOLIDATED MEDICAL EQUIPMENT 201803204

    Patients

    Seq Age Sex Outcome Treatment
    1