BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYF HND SWTCH PENCL AUTOCLAVAB

    MDR report key: 7722776 · Received July 26, 2018

    Report

    Report Number
    3007305485-2018-00177
    Event Type
    Malfunction
    Date Received
    July 26, 2018
    Date of Event
    June 29, 2018
    Report Date
    July 26, 2018
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT
    Product Code
    GEI
    UDI-DI
    20653405035999
    PMA / PMN Number
    K001159
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION FOUND THAT MULTIPLE DIFFERENT ELECTRODES WOULD FIRMLY INSERT INTO THE PENCIL. THE DEVICE WAS INSPECTED PER DRAWING. THE CONTACT COLLET WAS MEASURED WITH A PIN GAGE. THE CONTACT COLLET WAS FOUND TO BE WITHIN SPECIFICATION. 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 A TOTAL OF 9 COMPLAINTS, REGARDING 14 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4) 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 (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: CONTRAINDICTIONS: THE 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. THESE DEVICES SHOULD BE INSPECTED BEFORE USE. VISUALLY EXAMINE THE DEVICE FOR OBVIOUS PHYSICAL DAMAGE; CRACKED, BROKEN OR OTHERWISE DISTORTED PLASTIC PARTS. WARNINGS: USE OF THIS DEVICE BEYOND ITS INTENDED LIFE SPAN WILL EVENTUALLY RESULT IN FAILURE OF THE DEVICE AND PRESENT A POSSIBLE HAZARD. AT THAT POINT, THE DEVICE CANNOT BE REPAIRED AND SHOULD BE REPLACED WITH A NEW CONMED HANDPIECE. CARE IN THE USE AND HANDLING CAN ENSURE THE USEFUL LIFE OF THIS PRODUCT. INSPECTIONS: THESE DEVICES SHOULD BE INSPECTED BEFORE USE. VISUALLY EXAMINE THE DEVICE FOR OBVIOUS PHYSICAL DAMAGE. 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 7-900-5, HYF HND SWTCH PENCL AUTOCLAVAB, DEVICE TIP WOULD NOT STAY IN AND WAS FOUND TO BE DEFECTIVE BEFORE THE START OF THE CASE. THERE WAS NO PATIENT CONTACT PER THE REPORTER DUE TO THE FINDING BEING MADE DURING PRE-OP TESTING. THERE WAS NO DELAY OR CANCELLATION OF PROCEDURE PER THE REPORTER. 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
    565203 HYF HND SWTCH PENCL AUTOCLAVAB ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONSOLIDATED MEDICAL EQUIPMENT 201805224 20653405035999

    Patients

    Seq Age Sex Outcome Treatment
    1