BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS REUSABLE SURGICAL SCISSORS

    MDR report key: 2231572 · Received August 23, 2011

    Report

    Report Number
    8010047-2011-00192
    Event Type
    Other
    Date Received
    August 23, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 25, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION, HOWEVER VERY LITTLE INFORMATION WAS PROVIDED. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE DEVICE WAS RECEIVED IN A BIOHAZARD CONTAINER, WHICH LIMITED THE EVALUATION PRIMARILY TO VISUAL INSPECTION. THERE WAS DISCOLORATION, STAINING, AND MINOR SCRATCHES NOTED ON THE SURFACES OF THE SCISSORS BLADE. THE SCISSORS WERE FOUND TO OPERATE APPROPRIATELY DURING LIMITED OPERATION. THE DEVICE WAS FORWARDED TO THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) FOR FURTHER INVESTIGATION. THE FS-3L-1 INSTRUCTION MANUAL INTENDED USE STATEMENT SPECIFIES: THIS INSTRUMENT HAS BEEN DESIGNED TO BE USED WITH AN OLYMPUS ENDOSCOPE TO CUT TISSUE WITHIN THE DIGESTIVE TRACT. DO NOT USE THIS INSTRUMENT FOR ANY OTHER PURPOSE. THE FS-3L-1 INSTRUCTION MANUAL ALSO STATES: "WARNING: DO NOT USE THE INSTRUMENT TO CUT ANY OBJECTS OTHER THAN THE TARGET TISSUE (E.G., STENTS, METALLIC STENT WIRES, SEWING THREADS, AND LOOPS). IF ANYTHING OTHER T HAN THE TISSUE IS CUT, THE BLADES MAY BE DAMAGED OR THE CUT OBJECT MAY CAUGHT IN THE TAP OF THE INSTRUMENT, AND IT MAY BECOME DIFFICULT TO SAFELY REMOVE THE INSTRUMENT FROM THE BODY. THE SAME MANUAL ALSO STATES, "INCISION OF TISSUES MAY CAUSE BLEEDING. TO BE PREPARED FOR BLEEDING, BE SURE TO KEEP HEMOSTASIS EQUIPMENT READY." THE REPORTED PHENOMENON EVENT APPEARS DUE TO USER ERROR. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THEIR SURGICAL SCISSORS DID NOT CUT THE SUTURE DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE, AS THE SUTURE BECAME STUCK IN BETWEEN THE SCISSORS' BLADE, AND BLEEDING WAS SAID TO HAVE BEEN OBSERVED. NO FURTHER DETAILED INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS REUSABLE SURGICAL SCISSORS SURGICAL SCISSORS GEI OLYMPUS MEDICAL SYSTEMS CORPORATION FS-3L-1 K1326-4389

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention