BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEAM STER LOCKS ORANGE

    MDR report key: 6024500 · Received October 12, 2016

    Report

    Report Number
    2916714-2016-00806
    Event Type
    Injury
    Date Received
    October 12, 2016
    Date of Event
    August 11, 2016
    Report Date
    April 29, 2020
    Manufacturer
    AESCULAP INC
    Product Code
    KCT
    PMA / PMN Number
    K944864
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A RETROSPECTIVE REVIEW OF POTENTIAL SERIOUS INJURY COMPLAINTS WAS PERFORMED. THIS MDR WAS IDENTIFIED AND FILED AS PART OF THE REVIEW ACTIVITIES. B: SERIOUS INJURY AND DESCRIPTION UPDATED. D: BATCH NUMBER UPDATED. MULTIPLE ATTEMPTS WERE MADE FOR PRODUCT RETURN AND INVESTIGATION. (B)(4). AROUND 04/27/2017, THE SUPPLIER SCHWARZ STATED THAT THIS WAS THE ONLY COMPLAINT ON THIS LOT NUMBER WHICH THEY HAD RECIEVED FOR BRITTLE LOCKS, AND THEY WOULD CONTINUE TO MONITOR FOR THIS ISSUE. THE COMPANY ALSO DETERMINED THAT THE ADHESIVE ON THE DOTS WAS NOT STRONG ENOUGH; AND REQUESTED SAMPLE ROLL OF DOTS FROM SPS WITH A STRONGER ADHESIVE SO THEY COULD MANUFACTURE TEST SAMPLES AND MEASURE ADHESION FORCE. THIS ISSUE WAS ALSO MONITORED.

    Description of Event or Problem · 0

    CLARIFICATION WAS RECEIVED: THREE CASES IDENTIFIED THAT EXPERIENCED SURGICAL DELAY WITH PATIENTS UNDER ANESTHESIA: CASE 1 HAD A 25 MINUTE DELAY (THIS COMPLAINT). THE REPORTER STATED THAT SOME LOCKS AND DOTS WERE BREAKING OR FALLING OFF DURING STORAGE AND TRANSPORT, AND NOT THAT THE INDICATOR DOTS ON THE LOCKS WERE CHANGING COLOR. FURTHER PATIENT DETAILS WERE NOT PROVIDED. CASE 2, DELAY OF APPROXIMATELY 2 HOURS (CC# (B)(4) ). - REPORTED SEPARATELY. CASE 3, DELAY OF APPROXIMATELY 2 HOURS (CC # (B)(4)). -REPORTED SEPARATELY.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE INVESTIGATION IS ON-GOING. (B)(4). 510(K) K890764.

    Description of Event or Problem · 1

    (B)(6). CUSTOMER REPORTED THAT FOLLOWING PROCESSING OF STERIL CONTAINERS IT WAS OBSERVED THAT THE ORANGE LOCKS DOTS ARE CHANGING BACK TO BLUE. THE CUSTOMER STATED THAT THIS CAUSED A DELAY IN SURGERY BECAUSE THEY HAD TO REPROCESS SETS AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674599 STEAM STER LOCKS ORANGE PROCESS INDICATOR LOCK KCT AESCULAP INC US906 563744-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other