BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    SHRP ALL ARND ANG MYR BLD 6PK

    MDR report key: 15556639 · Received October 6, 2022

    Report

    Report Number
    3010692967-2022-00043
    Event Type
    Malfunction
    Date Received
    October 6, 2022
    Report Date
    October 5, 2022
    Manufacturer
    SURGICAL SPECIALTIES CORPORATION
    Product Code
    EMF
    UDI-DI
    10848782038197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THE FINISHED GOOD LOT AND ALL COMPONENTS MET REQUIREMENTS DURING THE INCOMING INSPECTION, MANUFACTURING, IN-PROCESS AND FINAL INSPECTION PROCESSES. NO SIMILAR COMPLAINTS WERE RECEIVED FOR THIS FINISHED GOOD LOT. THE ACTUAL DEVICE WAS BIOHAZARD AND COULD NOT BE DECONTAMINATED/RETURNED FOR REVIEW. THERE WERE TWO RETAINED SAMPLES AVAILABLE FOR REVIEW. BOTH DEVICES WERE VISUALLY EXAMINED. NO DEFECTS IN THE METAL OR FINISH WERE OBSERVED. PHOTOS OF THE BROKEN DEVICE WERE PROVIDED BY THE END USER FOR REVIEW. THE DEVICE WAS PHOTOGRAPHED WITHIN THE BIOHAZARD BAG. THE DEVICE APPEARED USED. THE CUTTING EDGE APPEARED DAMAGED/BROKEN. A CLEAR ANALYSIS COULD NOT BE PERFORMED AS THE PHOTOS BECOME DISTORTED WHEN MAGNIFIED. IF THE ACTUAL DEVICE IS DECONTAMINATED AND RETURNED AT A LATER TIME, IT WILL BE EXAMINED AND THE RESULTS WILL BE INCLUDED AS PART OF THE INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED AT THAT TIME. THE END USER PROVIDED ADDITIONAL INFORMATION ON (B)(6) 2022 THE END USER DID NOT NOTICE ANY ABNORMALITIES ON THE DEVICE PRIOR TO USE. THE DISTRIBUTOR ALSO SUBMITTED A REPORT TO THE FDA FOR THIS EVENT. THE REPORT NUMBER WAS NOT PROVIDED. A REVIEW OF THE MAUDE FDA SITE RESULTED IN 0 FINDINGS. THE DISTRIBUTOR''S COMPLAINT NUMBER ASSIGNED IS (B)(4). WITHOUT RECEIVING THE ACTUAL DECONTAMINATED DEVICE FOR REVIEW, RECEIVING STERILE SAMPLES FROM THE SAME LOT TO REVIEW/TEST, RECEIVING MAGNIFIED PHOTOS OF THE BREAKING POINT ON THE DEVICE OR RECEIVING DETAILED INFORMATION REGARDING THE METHOD UTILIZED TO REMOVE THE DEVICE FROM THE PACKAGING, PREOPERATIVE PREPARATION OF THE DEVICE, PROCEDURE PERFORMED, TOOLS UTILIZED IN CONJUNCTION WITH THE DEVICE OR THE SURGEON¿S TECHNIQUE, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 0

    THE END USER/UNIVERSITY OF (B)(6) REPORTED TO THE DISTRIBUTOR/MEDLINE THAT THE BLADE DEVICE BROKE IN THE PATIENT''S EAR DURING THE PROCEDURE. ANOTHER INSTRUMENT WAS REQUIRED TO RETRIEVE THE BROKEN PIECE. THE PIECE WAS REMOVED FROM THE PATIENT WITHOUT FURTHER INCIDENT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2507200 SHRP ALL ARND ANG MYR BLD 6PK EMF SURGICAL SPECIALTIES CORPORATION 72 C114HDX 10848782038197

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention