BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERAMIC ELECTRODE TIP L-HK F/GK372R

    MDR report key: 11686225 · Received April 19, 2021

    Report

    Report Number
    9610612-2021-00317
    Event Type
    Injury
    Date Received
    April 19, 2021
    Date of Event
    March 23, 2021
    Report Date
    July 14, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    GEI
    UDI-DI
    04038653172504
    PMA / PMN Number
    K970541
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WILL BE UPDATED, ONCE DEVICE IS RECEIVED BY THE MANUFACTURER. INVESTIGATION RESULTS: AS OF THE DATE OF THIS REPORT THE COMPLAINT PRODUCT WAS NOT PROVIDED FOR INVESTIGATION. THEREFORE, A THOROUGH INVESTIGATION IS NOT POSSIBLE. BATCH HISTORY REVIEW: DUE TO THE FACT THAT NO LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE COMPLAINED DEVICE IS NOT POSSIBLE. EXPLANATION AND RATIONALE UNFORTUNATELY DUE TO A LACK OF DATA AND WITHOUT THE PRODUCT WE CANNOT DETERMINE THE EXACT ROOT CAUSE FOR THE MENTIONED DEVIATION. ACCORDING TO THE QUALITY STANDARD, A PRODUCTION ERROR AND A MATERIAL DEFECT CAN MOST PROBABLY BE EXCLUDED. IF FURTHER INVESTIGATIONS ARE REQUIRED, THE PRODUCT SHOULD BE PROVIDED FOR EXAMINATION. BASED UPON THE INVESTIGATIONS RESULTS A CAPA IS NOT NECESSARY.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: VISUAL INVESTIGATION: THE INVESTIGATION WAS CARRIED OUT VISUALLY AND MICROSCOPICALLY WITH THE DIGITAL MICROSCOPE AND DIGITAL-CAMERA. WE MADE A VISUAL INSPECTION OF THE PRODUCT. HERE WE FOUND A LOOSENED CERAMIC BODY. IN ADDITION, WE CARRIED OUT A VISUAL INSPECTION OF THE FRACTURE SURFACE. NO ABNORMALITIES WERE DETECTED, BUT WE DISCOVERED UNKNOWN DEBRIS AND BLACK DISCOLORATION. BATCH HISTORY REVIEW: DUE TO THE FACT THAT NO LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE COMPLAINED DEVICE IS NOT POSSIBLE. REVIEW OF THE COMPLAINT HISTORY REVEALED THAT NO SIMILAR COMPLAINTS HAVE BEEN FILED AGAINST PRODUCTS FROM THIS BATCH NUMBER. THE REVIEW OF RISK ASSESSMENT REVEALED THAT THE OVERALL RISK LEVEL (SEVERITY 3(5) PROBABILITY OF OCCURRENCE 2(5)) ACCORDING TO DIN EN ISO 14971 IS STILL ACCEPTABLE. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: ACCORDING TO THE QUALITY STANDARD A MATERIAL DEFECT AND PRODUCTION ERROR CAN BE EXCLUDED. NO ABNORMALITIES COULD BE FOUND ON THE POINT OF RUPTURE. INVESTIGATIONS LEAD TO THE ASSUMPTION THAT THE LOOSENED CERAMIC BODY AND HOOK WERE CAUSED BY A MECHANICAL OVERLOAD SITUATION DUE TO AN IMPROPER HANDLING. THIS LEADS TO A BREAKAGE OR LOOSENING OF THE SOLDER CONNECTION. ADDITIONALLY THERE IS THE POSSIBILITY FOR PRE-DAMAGE OR SIMILAR DUE TO PREVIOUS SURGERIES. BASED UPON THE INVESTIGATIONS RESULTS A CAPA IS NOT NECESSARY.

    Description of Event or Problem · 0

    AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A CERAMIC ELECTRODE TIP. ACCORDING TO THE COMPLAINT DESCRIPTION, THE INNER METAL POST DETACHED. THE DEVICE MALFUNCTIONED TOWARDS THE END OF THE LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE SURGEON WAS REMOVING THE GALLBLADDER FROM THE LIVERBED, AND THE ELECTRODE TIP WAS IN TWO PIECES. EACH PART OF THE TIP WHICH HAD FALLEN INTO THE SURGICAL FIELD, WAS REMOVED USING A LAPAROSCOPIC GRASPER. THERE WAS A LESS THAN FIVE MINUTES DELAY DUE TO THE INCIDENT. THE SURGERY WAS COMPLETED USING ANOTHER AESCULAP MONOPOLAR INSTRUMENT. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585450 CERAMIC ELECTRODE TIP L-HK F/GK372R REUSABLE INSTRUMENTS GEI AESCULAP AG GK384R 04038653172504

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention