BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCULAN 4 DERMATOME 0.1MM

    MDR report key: 17729436 · Received September 12, 2023

    Report

    Report Number
    9610612-2023-00208
    Event Type
    Malfunction
    Date Received
    September 12, 2023
    Date of Event
    October 26, 2022
    Report Date
    September 12, 2023
    Manufacturer
    AESCULAP AG
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A SIMILAR DEVICE REPORT. INVESTIGATION RESULTS: THE INVESTIGATION WAS CARRIED OUT BY A SUBJECT MATTER EXPERT IN AESCULAP TECHNICAL SERVICE(ATS). THE CUTTING GAP IS A BIT TOO NARROW. RESIDUES ON SIDE PARTS AND CLAMPING LEVER. THE GOLD LOCKING SCREW IS DAMAGED. THE DERMATOME PLATE SHOWS A DAMAGE AND SIGNS OF WEAR. DEVICE HISTORY RECORDS: SINCE A REPAIR WAS PERFORMED AND THIS WAS IDENTIFIED AS THE CAUSE, A REVIEW OF THE DEVICE HISTORY RECORDS IS NOT NECESSARY. THE CURRENT FAILURE RATE IS WITHIN THE RISK ANALYSIS AND THEREFORE ACCEPTABLE; SEVERITY WAS 3(5) AND PROBABILITY WAS 1(5). EXPLATION AND RATIONALE: CHECKING THE CUTTING GAP ACCORDING TO TEST SPECIFICATIONS REVEALED A MINIMAL DEVIATION ON ONE SIDE. THE REASON FOR THE DEVIATION IS MOST LIKELY CAUSED FROM MISHANDLING. THE GOLDEN LOCKING SCREW SHOWS SIGNS OF MISUSE BY USING A PAIR OF PLIERS OR OTHER TOOL TO UNLOCK OR LOCK THE SCREW. BECAUSE OF THIS HIGH FORCE THE CUTTING GAP COULD BE CHANGED. A CUTTING TEST SHOWED NO DEVIATION IN THE CUTTING PATTERN AT THE 0.2 AND 0.1 SETTING. THEREFORE, THE CUSTOMER'S ERROR CANNOT BE CONFIRMED. THE DAMAGE TO THE DERMATOME PLATE IS VISIBLE, BUT THE CAUSE CANNOT BE CLEARLY DETERMINED. DELIVERY WITH THIS DAMAGE CAN BE EXCLUDED BY THE FINAL INSPECTION THAT WAS CARRIED OUT DURING THE LAST REPAIR. THE PICTURES CLEARLY SHOW THAT THE PRODUCT HAS ALREADY BEEN REPROCESSED AT THIS TIME. THEREFORE, IT COULD NOT BE AN "OUT OF BOX" DEFECT. CONCLUSION/PREVENTIVE MEASURES: BASED UPON THE ABOVE MENTIONED INVESTIGATION RESULTS, THE ROOT CAUSE FOR THE ISSUE IS MOST PROBABLY HANDLING AND REPROCESSING-RELATED. BASED UPON THE INVESTIGATION RESULTS, A CAPA IS NOT NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH GA341 - ACCULAN 4 DERMATOME 0.1MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE SKIN WAS SPARSELY HARVESTED, AND DIFFICULT FOR BLADE TO PENETRATE SKIN. THERE WAS TEMPORARY IMPAIRMENT; SKIN GRAFT INSUFFICIENTLY HARVESTED. ADDITIONAL INFORMATION WAS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4). INVOLVED COMPONENT: GA346/ACCULAN 4 LI-ION BATTERY SHORT - LOT 52599506.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801512 ACCULAN 4 DERMATOME 0.1MM LARGE BONE POWER SYSTEMS HWE AESCULAP AG GA341 52579355

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown GA346 - LOT 52599506