BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KITTNER, LAPROSCOPIC BLUNT DISSECTOR 

    MDR report key: 23568870 · Received November 17, 2025

    Report

    Report Number
    2320762-2025-00018
    Event Type
    Malfunction
    Date Received
    November 17, 2025
    Date of Event
    September 1, 2025
    Report Date
    December 18, 2025
    Manufacturer
    MEDSORB DOMINICANA, S.A.
    Product Code
    GDI
    UDI-DI
    00749756025355
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED THROUGH A MEDWATCH, "DURING SURGERY, SURGEON REMOVED 5MM LAPAROSCOPIC KITTNER DISSECTOR FROM THE ABDOMEN, AND THE SCRUB TECH NOTICED THE TIP PIECE OF KITTNER WAS NOT ATTACHED. SURGEON WAS ABLE TO LOCATE THE KITTNER TIP AND SAFELY REMOVE IT FROM THE PATIENT." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, HOWEVER, IT WAS LISTED AS UNAVAILABLE FOR RETURN. DEROYAL REVIEWED THE WORK ORDER FOR THE LOT NUMBER OF THE DEVICE AND FOUND NO ISSUES. AN INVENTORY CHECK WAS PERFORMED ON FOUR CASES OF FINISHED PRODUCT AND TEN EACHES OF THE RAW MATERIAL FROM THE SUPPLIER AND ALL WERE FOUND TO BE ACCEPTABLE. THE RISK ANALYSIS WAS REVIEWED AND WAS FOUND TO BE UP TO DATE AND DID NOT REQUIRE ANY UPDATES. A COMPLAINT TO SALES RATIO WAS CONDUCTED OVER THE PAST TWO YEARS AND FOUND TO BE (B)(4). A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WILL BE ISSUED TO THE SUPPLIER, (B)(4). THE SUPPLIER REVIEWED THE DEVICE HISTORY RECORD, MANUFACTURING PROCESS, AND COMPLAINT RECORDS. THE INVENTORY AND WORK IN PROCESS PRODUCT WERE ALSO REVIEWED AND FOUND TO BE WITHIN MANUFACTURING SPECIFICATIONS. ROOT CAUSE: WHILE NO SAMPLE WAS ABLE TO BE RETURNED, BECAUSE OF A PREVIOUS COMPLAINT OF THIS NATURE, THE SUPPLIER DETERMINED THE ROOT CAUSE TO BE AN INADEQUATE GLUE APPLICATION ON THE DISSECTOR. WITH THE PREVIOUS COMPLAINT, IT WAS DISCOVERED THAT THERE WAS A LACK OF COMPLIANCE WITH THE PROCEDURE. ACTIONS WERE TAKEN AS STATED BELOW, BUT THE SUPPLIER NOTED THAT THIS WORK ORDER TOOK PLACE PRIOR TO THE CORRECTIVE ACTIONS. CORRECTIVE AND PREVENTIVE ACTIONS: CORRECTIVE AND PREVENTIVE ACTIONS WERE TAKEN ON THE PREVIOUS COMPLAINT AND WOULD ALSO APPLY TO THIS POTENTIAL ROOT CAUSE. THIS PREVIOUS COMPLAINT NUMBER (B)(4) AND SUBMITTED WITH MDR # 2320762-2025-00003. BECAUSE OF THE LACK OF COMPLIANCE TO THE PROCEDURE, RETRAINING WAS CONDUCTED ON THE GLUING WORK INSTRUCTIONS AND STATES THAT ALL WORK PERSONNEL SHOULD BE RETRAINED EVERY SIX MONTHS ON THE PROCEDURE AS WELL AS WITH TRAINING VIDEOS SHOWING THE PROPER GLUING ASSEMBLY. PERIODIC REFRESHER TRAINING HAS ALSO BEEN IMPLEMENTED FOR INSPECTION ASSOCIATES TO ENSURE CONSISTENT UNDERSTANDING OF INSPECTION CRITERIA TO REVIEW THE GLUING ASSEMBLY. DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS AROUND THIS ITEM AND ISSUE. THIS INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED THROUGH A MEDWATCH, "DURING SURGERY, SURGEON REMOVED 5MM LAPAROSCOPIC KITTNER DISSECTOR FROM THE ABDOMEN, AND THE SCRUB TECH NOTICED THE TIP PIECE OF KITTNER WAS NOT ATTACHED. SURGEON WAS ABLE TO LOCATE THE KITTNER TIP AND SAFELY REMOVE IT FROM THE PATIENT." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, HOWEVER, IT WAS LISTED AS UNAVAILABLE FOR RETURN. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE SUPPLIER, (B)(4). THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW UP REPORT WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED THROUGH A MEDWATCH, "DURING SURGERY, SURGEON REMOVED 5MM LAPAROSCOPIC KITTNER DISSECTOR FROM THE ABDOMEN, AND THE SCRUB TECH NOTICED THE TIP PIECE OF KITTNER WAS NOT ATTACHED. SURGEON WAS ABLE TO LOCATE THE KITTNER TIP AND SAFELY REMOVE IT FROM THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2859155 KITTNER, LAPROSCOPIC BLUNT DISSECTOR  DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY GDI MEDSORB DOMINICANA, S.A. 28-0801 62095439 00749756025355

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown