BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENCIL, H2K, PUSHBUTTON

    MDR report key: 10516379 · Received September 10, 2020

    Report

    Report Number
    3007305485-2020-00392
    Event Type
    Malfunction
    Date Received
    September 10, 2020
    Report Date
    October 5, 2020
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT
    Product Code
    GEI
    PMA / PMN Number
    K001159
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION OF THE RETURNED DEVICE FOUND THAT THE HYFRECATOR HAND SWITCHING PENCIL HAS COME APART. THE PENCIL IS UNREPAIRABLE. 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 WAS 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 A TOTAL OF TWO COMPLAINTS, REGARDING TWO DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME 335 DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE 0.006. PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: CONTRAINDICATIONS: THIS DEVICE SHOULD NEVER BE USED WHEN: THERE IS VISIBLE EVIDENCE OF DAMAGE TO THE EXTERIOR OF THE DEVICE, SUCH AS CRACKS, CUTS, PUNCTURES, NICKS, ABRASIONS, DISCOLORATION OR CONNECTOR DAMAGE. WARNING: DO NOT PULL ON OR STRETCH THE HANDPIECE CORD. INSPECTION: THESE DEVICES SHOULD BE INSPECTED BEFORE USE. VISUALLY EXAMINE THE DEVICES FOR OBVIOUS PHYSICAL DAMAGE: CRACKED, BROKEN OR OTHERWISE DISTORTED PLASTIC PARTS; DAMAGE INCLUDING CUTS, PUNCTURES, NICKS, ABRASIONS, UNUSUAL LUMPS OR SIGNIFICANT DISCOLORATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE HAS BEEN RETURNED TO CONMED; HOWEVER, THE EVALUATION OF THE DEVICE HAS NOT BEEN COMPLETED. 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 CUSTOMER REPORTED THAT THE DEVICE, 7-900-5, SEPARATED AT THE PROXIMAL END OF THE HANDPIECE HOUSING SHORTLY AFTER PURCHASE; HOWEVER, THE DATE OF THE OCCURRENCE IS UNKNOWN. THERE WAS NO PROCEDURE SCHEDULED OR PATIENT INVOLVED. THERE WAS NO REPORT OF INJURY TO USER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981752 PENCIL, H2K, PUSHBUTTON ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONSOLIDATED MEDICAL EQUIPMENT 202003264

    Patients

    Seq Age Sex Outcome Treatment
    1