BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARBON STEEL SAFETY SCALPEL #23

    MDR report key: 11731525 · Received April 27, 2021

    Report

    Report Number
    9610612-2021-00328
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    March 29, 2021
    Report Date
    September 2, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    GDX
    UDI-DI
    04046963510749
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: LEADING DEVICE. REFERENCE CODE (B)(4). DEVICE NAME CARBON STEEL SAFETY SCALPEL #23. SERIAL NUMBER N/A. BATCH NUMBER 4512049006. MANUFACTURING DATE 16.10.2020. PRODUCTS ARE AVAILABLE FOR INVESTIGATION. FAILURE DESCRIPTION. ONE SAMPLE BEEN SENT FOR INVESTIGATION AND SHOWED A DAMAGED FOIL. VIGILANCE INVESTIGATOR CARRIED OUT THE PICTORIAL DOCUMENTATION VISUALLY AND MICROSCOPICALLY. THE SAMPLE IS SHOWING A RESTED PART OF THE PE FOIL ON THE SEALING AREA AND THE OTHER PART TORN AND LOOSENED FROM THE SEALING AREA. AS THERE IS NO HINT FOR A MATERIAL ISSUE ON THE FOIL ITSELF AND DUE TO TESTS PERFORMED DURING AN EARLIER COMPLAINT (B)(4) WHICH SHOWED NO DEVIATION REGARDING THE SEALING, WE THEREFORE ASSUME THAT THERE IS NO MANUFACTURING ISSUE. BATCH HISTORY REVIEW. THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBER AND WERE FOUND TO BE ACCORDING TO OUR SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THERE ARE NO SIMILAR COMPLAINTS AGAINST THE SAME LOT NUMBER WITH THIS ERROR PATTERN. EXPLANATION AND RATIONALE BASED ON OUR INVESTIGATION OF THE AFFECTED SAMPLE AND THE FACT THAT IN 5 YEARS ONLY TWO COMPLAINTS FROM TWO DIFFERENT CUSTOMERS HAVE BEEN REPORTED REGARDING THIS ISSUE, WE ASSUME THAT THERE IS NO PRODUCT DEVIATION. CONCLUSION AND ROOT CAUSE DUE TO THE CURRENT DEVIATION AND ACCORDING TO THE EXPLANATION AND RATIONALE, THE ROOT CAUSE OF THE PROBLEM IS MOST PROBABLY USAGE-RELATED. THERE IS ACTUALLY NO HINT REGARDING A MANUFACTURING ISSUE AS THE SEALING BOARDERS ARE EXISTENT AND THE SEALING PROCESS IS VALIDATED. A PEEL FORCE MEASUREMENT SHOWED NO DEVIATION FROM THE EXPECTABLE FORCE. ADDITIONALLY, THERE ARE ONLY COMPLAINTS FROM TWO DIFFERENT CUSTOMERS REGARDING THIS ISSUE IN THE LAST 5 YEARS. BASED UPON THE INVESTIGATIONS RESULTS A CAPA IS NOT NECESSARY.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. THIS IS A SIMILAR DEVICE REPORT. THE INVOLVED DEVICE IS NOT MARKETED IN THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH BA823SU - CARBON STEEL SAFETY SCALPEL #23. ACCORDING TO THE COMPLAINT DESCRIPTION, THE PRIMARY PACKAGING-TORN. THE PACKAGING OF THE SCALPEL (PRIMARY PACKAGING) TORE, CAUSING THE EQUIPMENT IS NOT STERILE. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629850 CARBON STEEL SAFETY SCALPEL #23 DISPOSABLE SCALPELS GDX AESCULAP AG BA823SU 4512049006 04046963510749

    Patients

    Seq Age Sex Outcome Treatment
    1