BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROBE HOOK HOOK LENGTH 3MM 230MM

    MDR report key: 8653533 · Received May 30, 2019

    Report

    Report Number
    9610612-2019-00354
    Event Type
    Malfunction
    Date Received
    May 30, 2019
    Date of Event
    March 26, 2019
    Report Date
    June 4, 2019
    Manufacturer
    AESCULAP AG
    Product Code
    HRX
    PMA / PMN Number
    K003740
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. (B)(4)) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER, REGISTRATION NO. (B)(4)). EXEMPTION NUMBER: E2014018. INVESTIGATION: THE INVESTIGATION WAS CARRIED OUT VISUALLY AND MICROSCOPICALLY WITH THE DIGITAL MICROSCOPE. WE MADE A VISUAL INSPECTION OF THE INSTRUMENT AND OF THE FRACTURE SURFACE. HERE WE FOUND A BENT PROBE. ADDITIONALLY WE MADE AN OPTICAL INSPECTION OF THE FRACTURE SURFACE. WE DETECTED DARK DISCOLORATION BUT NO ANOMALIES. BATCH HISTORY REVIEW: THE PRODUCT DOES NOT REQUIRE BATCH MANAGEMENT; A REVIEW OF THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS IS NOT POSSIBLE. CONCLUSION AND ROOT CAUSE: THE ROOT CAUSE OF THE PROBLEM IS MOST PROBABLY USAGE RELATED AND REPROCESSING RELATED. RATIONALE: ACCORDING TO THE QUALITY STANDARD A MATERIAL DEFECT AND PRODUCTION ERROR CAN BE EXCLUDED. INVESTIGATIONS LEAD TO THE ASSUMPTION THAT THE BREAKAGE WAS CAUSED STRESS CORROSION CRACKING. WE ASSUME A P-DAMAGE DUE TO A MECHANICAL OVERLOAD SITUATION. THIS OVERLOAD SITUATION LED TO THE BENT PROBE FO702200. WE ALSO ASSUME THAT THE BLACK DISCOLORATION ARE SIGNS OF AN OLD CRACK. DUE TO THE EXISTING PRE-DAMAGE OR WEAK POINT, THE REPROCESSING WAS FRACTURE-TRIGGERING. NO CPAP NECESSARY.

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER, REGISTRATION NO. 9610612). EXEMPTION NUMBER: E2014018. WHEN ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE INSTRUMENT BROKE INTRA-OPERATIVELY. THE REPORTER INDICATED DURING AN ARTHROSCOPIC PROCEDURE THE DEVICE BROKE DURING USE. AN ADDITIONAL INCISION POSTERIOR ROUTE WAS REQUIRED TO RECOVER THE FORCEPS. REMOVAL OF THE BROKEN DEVICE WAS PERFORMED WITH A CLAMP AND PASSING BY THE POSTERIOR ROUTE. PATIENT INFORMATION HAS NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER, NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447289 PROBE HOOK HOOK LENGTH 3MM 230MM REUSABLE INSTRUMENTS HRX AESCULAP AG FO701R

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention