BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENS 4K A/C CAMERA HEAD

    MDR report key: 12257336 · Received August 1, 2021

    Report

    Report Number
    1643264-2021-02238
    Event Type
    Injury
    Date Received
    August 1, 2021
    Date of Event
    July 8, 2021
    Report Date
    February 16, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GCJ
    UDI-DI
    00885556720790
    PMA / PMN Number
    K191177
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE, USED IN TREATMENT, WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION, THUS VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION OR WOULD NOT BE ABLE TO PERFORM AS INTENDED. A COMPLAINT HISTORY REVIEW CONCLUDED THIS WAS A REPEAT ISSUE. A RELATIONSHIP, IF ANY, BETWEEN THE SUBJECT DEVICE AND THE REPORTED EVENT COULD NOT BE DETERMINED. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR RECOMMENDATIONS ON PROPER USE OF THE DEVICE AND POTENTIAL TROUBLESHOOTING METHODS TO PREVENT FUTURE REOCCURRENCE OF THE REPORTED EVENT. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS EVALUATION WILL BE REOPENED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE NOTED RESIDUE ON THE CONNECTOR CONTACTS. FUNCTIONAL EVALUATION REVEALED THAT THERE WAS LOSS OF IMAGE WHEN THE CONNECTOR IS MOVED. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION OR WOULD NOT BE ABLE TO PERFORM AS INTENDED. A COMPLAINT HISTORY REVIEW CONCLUDED THIS WAS A REPEAT ISSUE. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. IT WAS DETERMINED THE DEVICE DID NOT CONTRIBUTE TO THE REPORTED EVENT. THE COMPLAINT WAS CONFIRMED AND THE ROOT CAUSE WAS ASSOCIATED WITH UNINTENDED USE OF THE DEVICE. THE INSTRUCTIONS FOR USE (IFU), PROVIDED WITH THE DEVICE, CONTAIN THE FOLLOWING WARNINGS AND PRECAUTIONARY MEASURES RELATED TO PROPER USE OF THE DEVICE, INCLUDING BUT NOT LIMITED TO: THE PRODUCT MUST BE CLEANED AND STERILIZED BEFORE EVERY SUBSEQUENT USE; USE ONLY NEUTRAL PH CLEANERS TO DECONTAMINATE THE CAMERA HEAD. NON-NEUTRAL PH CLEANERS MAY CAUSE RESIDUE BUILDUP, WHICH MAY CAUSE INTERFERENCE IN THE VIDEO OUTPUT. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT REFERENCE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MENISCECTOMY SURGERY, THE CAMERA HEAD STOPS TRANSMITTING IMAGE UNCONTROLLED. THE PROCEDURE WAS COMPLETED WITH A SIGNIFICANT DELAY USING A BACK-UP DEVICE. ADDITIONAL ANESTHESIA WAS REQUIRED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154478 LENS 4K A/C CAMERA HEAD LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ SMITH & NEPHEW, INC. 72205058 00885556720790

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other