BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TC TENOTOMY SCISSDELCVD1/SERR130MM

    MDR report key: 6917885 · Received October 5, 2017

    Report

    Report Number
    9610612-2017-00492
    Event Type
    Malfunction
    Date Received
    October 5, 2017
    Date of Event
    August 18, 2017
    Report Date
    March 6, 2018
    Manufacturer
    AESCULAP AG
    Product Code
    EGN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: USA. TIPS OF TENOTOMY SCISSOR BROKE OFF & HINGE BROKE. SCISSOR BROKE WHILE SURGEON WAS USING IT. IT ENDED UP IN 4 PIECES. X-RAY WAS NEGATIVE, ALL PIECES ARE ACCOUNTED FOR. TYPE OF SURGERY UNKNOWN AT THIS TIME, ENQUIRY HAS BEEN MADE. NO PATIENT HARM REPORTED. NO SURGICAL DELAY REPORTED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE COMPONENTS HAVE BEEN EXAMINED VISUALLY AND MICROSCOPICALLY WITH A KEYENCE VHX-5000 DIGITAL MICROSCOPE AND A PANASONIC DMC TZ8 DIGITAL CAMERA. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBER. THE DEVICE HISTORY FILE HAS BEEN CHECKED AND FOUND TO BE ACCORDING TO OUR SPECIFICATION VALID AT THE TIME OF PRODUCTION. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THIS BATCH. CONCLUSION AND ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF OUR INVESTIGATION, THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY RELATED TO AN INSUFFICIENT MAINTENANCE OF THE DEVICE. RATIONAL: THE CORROSION ON THE SCISSORS IS A SO-CALLED "STRESS CORROSION", CAUSED IN COMBINATION WITH A MECHANICAL TENSION. THIS TYPE OF CORROSION OFTEN AFFECTS AREA OR COMPONENTS THAT HAVE BEEN SUBJECTED TO HIGH TENSILE STRESS. THIS CAN BE DUE TO DESIGN LIMITATIONS SUCH AS SCREW CONNECTIONS. REPROCESSING OF THE INSTRUMENT IN A STATE OF HIGH TENSION (FOR EXAMPLE, CLOSED BLADES DURING REPROCESSING) CAN SPEED UP THE DEFECT. NO CAPA IS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698651 TC TENOTOMY SCISSDELCVD1/SERR130MM DENTAL SCISSORS EGN AESCULAP AG DO250R 1208530B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other