BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS DISPOSABLE HOT BIOPSY FORCEPS

    MDR report key: 2470988 · Received February 23, 2012

    Report

    Report Number
    8010047-2012-00048
    Event Type
    Injury
    Date Received
    February 23, 2012
    Date of Event
    January 25, 2012
    Report Date
    January 25, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    KGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN MORE DETAILED INFO REGARDING THE REPORT, AND WAS INFORMED THAT THE BIOPSY FORCEPS WERE REPLACED WITH A DIFFERENT FORCEPS AFTER THE USERS REPORTEDLY OBSERVED THE ELECTRICAL SPARKS AND THE MUCOSAL MOVEMENT. THE PERFORATION WAS SAID TO HAVE BEEN DISCOVERED AFTER THE PT REPORTED FEELING PAIN IN THE ABDOMEN DURING RECOVERY. THE PERFORATION WAS SAID TO BE IN THE SAME LOCATION AS THE POLYPECTOMY SITE. THE USER INDICATED THEY SUSPECTED THE HOT FUNCTIONS OF THE BIOPSY FORCEPS CAUSED THE PERFORATION. THE PROCEDURE TO ADDRESS THE PERFORATION WAS PERFORMED ON THE SAME DAY OF THE INITIAL PROCEDURE. THE PT WAS SAID TO HAVE BEEN DISCHARGED FROM THE HOSPITAL AFTER AN UNSPECIFIED PERIOD OF TIME. THE DEVICE REFERENCE IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVAL, AS IT WAS DISCARDED BY THE USER FACILITY FOLLOWING THE PROCEDURE. REVIEW OF THE COMPLAINT SYSTEM IDENTIFIED NO SIMILAR REPORTS ASSOCIATED WITH THE LOT NUMBER REFERENCED IN THIS REPORT. THE EXACT CAUSE OF THE USER'S REPORT COULD NOT BE CONCLUSIVELY DETERMINED. THE (B)(4) INSTRUCTIONS FOR USE STATE: WARNING: WHEN APPLYING THE CURRENT, DO NOT USE AN EXCESSIVE AMOUNT OF CONDUCTION. DOING SO COULD CAUSE PT INJURY SUCH AS PERFORATIONS AND/OR BLEEDING. WHEN NECESSARY, PROVIDE TREATMENTS AND/OR BLEEDING. WHEN NECESSARY, PROVIDE TREATMENTS TO PREVENT PERFORATIONS OR BLEEDING FROM OCCURRING AFTER THE PROCEDURE, AND CONFIRM THAT NO ABNORMALITIES ARE FOUND IN THE PT. 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 DURING A THERAPEUTIC COLONOSCOPY WITH POLYPECTOMY, THE USER REPORTEDLY OBSERVED ELECTRIC SPARKS AT THE DISTAL TIP OF THE ENDOSCOPE, AND CLAIMED TO HAVE OBSERVED SPASMS IN MUCOSA THAT DID NOT SEEM RELATED TO PT MOVEMENT. THE USER FURTHER REPORTED THAT THE PT WAS DETERMINED TO HAVE A PERFORATION FOLLOWING THE PROCEDURE. THE PT REQUIRED AN ADD'L PROCEDURE TO TREAT THE PERFORATION, AND AN ILEOSTOMY WAS PERFORMED. THE CURRENT STATUS OF THE PT IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS DISPOSABLE HOT BIOPSY FORCEPS BIOPSY FORCEPS KGE OLYMPUS MEDICAL SYSTEMS CORPORATION FD-230U 17K

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS ELECTROSUGICAL UNIT: MODEL ESG-100,| SERIAL NUMBER (B)(4)