BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE FUNCTION HNDPC ABC ELEC

    MDR report key: 8623650 · Received May 20, 2019

    Report

    Report Number
    3007305485-2019-00150
    Event Type
    Malfunction
    Date Received
    May 20, 2019
    Report Date
    July 19, 2019
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT
    Product Code
    HAM
    PMA / PMN Number
    K871435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED ONE 130344 IN UNOPENED ORIGINAL PACKAGING. LOT NUMBER WAS VERIFIED. PERFORMED A VISUAL INSPECTION OF THE DEVICE, THERE WERE NO OBVIOUS SIGNS OF A BREACH. PERFORMED A FUNCTIONAL INSPECTION, THE DEVICES WERE DYE LEAK TESTED WHICH INDICATED THAT THE PACKAGING DID NOT HAVE 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 WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THERE HAVE BEEN TWO COMPALINTS 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 4 COMPLAINTS, REGARDING (B)(4) 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: CONTRAINDICATIONS: THESE DEVICES SHOULD NEVER BE USED WHEN: THERE IS VISIBLE EVIDENCE OF DAMAGE TO THE EXTERIOR OF THE DEVICE SUCH AS CUTS, PUNCTURES, NICK ABRASIONS, UNUSUAL LUMPS OR SIGNIFICANT DISCOLORATION. INSPECTION: THESE DEVICES SHOULD BE INSPECTED BEFORE EACH USE. VISUALLY EXAMINE THE DEVICES FOR OBVIOUS PHYSICAL DAMAGE AND DO NOT USE IF DAMAGE IS FOUND: CRACKED, BROKEN OR OTHERWISE DISTORTED PLASTIC PARTS BROKEN OR SIGNIFICANTLY BENT CONNECTOR CONTACTS 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

    DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 130344, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. DUE TO THE POTENTIAL SEVERITY OF A BREACH IN STERILITY, THIS COMPLAINT MEETS THE CRITERIA FOR A REPORTABLE EVENT. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418719 SINGLE FUNCTION HNDPC ABC ELEC APPARATUS, ELECTROSURGICAL HAM CONSOLIDATED MEDICAL EQUIPMENT 201806204

    Patients

    Seq Age Sex Outcome Treatment
    1