BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TC TENOTOMY SCISSDELCVD1/SERR130MM

    MDR report key: 7343488 · Received March 15, 2018

    Report

    Report Number
    9610612-2018-00100
    Event Type
    Malfunction
    Date Received
    March 15, 2018
    Date of Event
    August 29, 2016
    Report Date
    March 15, 2018
    Manufacturer
    AESCULAP AG
    Product Code
    EGN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: THE TIP OF THE SCISSORS ARE BROKEN. PICTORIAL DOCUMENTATION WAS CARRIED OUT WITH A DIGITAL MICROSCOPE. HARDNESS MEASUREMENT WAS CARRIED OUT WITH HARDNESS TESTER. THE DEVICE HISTORY FILES HAVE BEEN CHECKED AND WERE FOUND TO BE ACCORDING TO THE SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF THE INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY RELATED TO AN INSUFFICIENT USAGE. THIS KIND OF INSTRUMENT IS DESIGNATED FOR DELICATE USE ONLY. IT IS LIABLE THAT A MECHANICAL OVERLOAD SITUATION LED TO THE BREAKAGE. THE VISUAL INVESTIGATION AND THE HARDNESS TEST INDICATED THAT THE QUALITY REQUIREMENTS ARE IN THE SPECIFIED TOLERANCE RANGE. A CAPA IS NOT NECESSARY.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: USA. CUSTOMER STATES THAT DURING INTRA-OPERATIVE SURGERY THE TIP OF SCISSORS BROKE OFF. NO SURGICAL DELAY AND NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186005 TC TENOTOMY SCISSDELCVD1/SERR130MM DENTAL SCISSORS EGN AESCULAP AG DO250R 4507434213

    Patients

    Seq Age Sex Outcome Treatment
    1 Other