BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPARE CUTTER F/GB304R/GB305R/GB308R

    MDR report key: 9124650 · Received September 26, 2019

    Report

    Report Number
    9610612-2019-00661
    Event Type
    Injury
    Date Received
    September 26, 2019
    Date of Event
    August 30, 2019
    Report Date
    December 10, 2019
    Manufacturer
    AESCULAP AG
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: THE DEVICES ARE IN A USED CONDITION. THE INVESTIGATION HAS BEEN CARRIED OUT BY THE AESCULAP TECHNICAL SERVICE (ATS). TE563 SPARE CUTTER (52107655). THE COMPLAINED SPARE CUTTER WAS MANUFACTURED IN NOVEMBER 2008. THE LAST REPAIR TOOK PLACE IN JANUARY 2018 DUE TO BLUNT CUTTING EDGES. OPTICALLY, THE PRODUCT IS IN A BAD CONDITION. THE CUTTING EDGES ARE SHOWING CLEAR DAMAGES. THEREFORE THE CUTTING BEHAVIOUR IS BAD. STRONG PRESSURE IS NECESSARY TO CUT. DUE TO THE DAMAGES OF THE CUTTING EDGES A CORRECT COUPLING IS NO LONGER GUARANTEED. GB169R MICRO LINE DRILL (BATCH 51443690, SERIAL (B)(4)). MANUFACTURED IN 2007. NO FAILURE COULD BE DETECTED AT THE HANDPIECE. A LASER ENGRAVING SHOWS "ATS1207 JPN" AND INDICATES THAT THE LAST MAINTENANCE WAS CARRIED-OUT IN JULY 2012. A FURTHER MAINTENANCE IS THEREFORE RECOMMENDED. GB106R HUDSON CHUCK. NO FAILURE COULD BE DETECTED AT THE HUDSON CHUCK. A LASER ENGRAVING SHOWS "ATS1207 JPN" AND INDICATES THAT THE LAST MAINTENANCE WAS CARRIED-OUT IN JULY 2012. A FURTHER MAINTENANCE IS THEREFORE RECOMMENDED. GA173 MICRO FLEXIBLE CABLE (BATCH 51515470, SERIAL (B)(4)). THE FLEXIBLE CABLE WAS MANUFACTURED IN NOVEMBER 2018. OPTICALLY, THE PRODUCT IS IN A USED CONDITION. A FUNCTIONAL TEST REVEALS RUNNING NOISES AND A WORN CONDITION IN GENERAL. A LASER ENGRAVING SHOWS "ATS1207 JPN" AND INDICATES THAT THE LAST MAINTENANCE WAS CARRIED-OUT IN JULY 2012. A FURTHER MAINTENANCE IS THEREFORE RECOMMENDED. BATCH HISTORY REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBERS AND FOUND TO BE ACCORDING TO THE SPECIFICATION, VALID AT THE TIME OF PRODUCTION. NO FURTHER COMPLAINTS REGISTERED AGAINST ANY OF THE ABOVE MENTIONED LOT NUMBERS. CONCLUSION AND ROOT CAUSE - THE FAILURE IS MOST PROBABLY USAGE / MAINTENANCE RELATED. RATIONALE - REFER TO INVESTIGATION. A WARNING NOTE REGARDING BLUNT CUTTING EDGES CAN BE FOUND IN THE INSTRUCTIONS FOR USE (IFU): "RISK TO PATIENT IF THE BLADES ARE DAMAGED; RISK OF BURNS TO SKIN AND TISSUE CAUSED BY BLUNT TOOLS".

    Description of Event or Problem · 0

    MATERIAL NUMBER CHANGED FROM GB304R TO TE563 ON THE BASIS OF THE LASER ENGRAVING ON THE RECEIVED PRODUCT. ASSOCIATED MEDWATCH-REPORTS: 400443989_9610612-2019-00662, 400443990_9610612-2019-00663, AND 400443991_9610612-2019-00664.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PRODUCT CRANIAL PERFORATOR 12/15 MM HUDSON SHANK. DURING BURRHOLE SURGERY (LEFT TEMPORALCRANIOTOMY) WHEN THE CRANIOTOME BLADE REACHED THE HEMATOMA, THE BLADE INJURED THE PATIENTS DURA MATER. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. THE INJURY WAS SUTURED BY THE SURGEON, AND , BY SUTURING THE INJURED PART, IT TOOK EXTRA TIME IN THE SURGICAL PROCEDURE (NOT KNOWN HOW LONG). THE PROCEDURE WAS FINISHED AND, SO FAR , THERE HAS NOT BEEN ANY FURTHER COMPLICATIONS TO THE PATIENT REPORTED TO US. THE SURGEON STATED THAT THE BLADE INJURED THE DURA MATER, PROBABLY BECAUSE OF THE THIN SKULL, BUT HE WANTS TO HAVE THE DEVICE CHECKED TO SEE IF THERE WAS ANY DEFECT. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4). ASSOCIATED MEDWATCH-REPORTS: 400443989_9610612-2019-00662, 400443990_9610612-2019-00663, 400443991_9610612-2019-00664.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918251 SPARE CUTTER F/GB304R/GB305R/GB308R HIGHSPEED POWER SYSTEMS HWE AESCULAP AG TE563 52107655

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention