BEUDAMED
    FDA Adverse Event Other Summary report: N

    ELECTRO SURGICAL INSTRUMENT COMPANY

    MDR report key: 2931601 · Received January 22, 2013

    Report

    Report Number
    1315756-2013-00001
    Event Type
    Other
    Date Received
    January 22, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 18, 2013
    Manufacturer
    ELECTRO SURGICAL INSTRUMENT COMPANY
    Product Code
    FDG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIBEROPTIC RETRACTOR AND CABLE WERE RETURNED TO ESI ON (B)(4) 2013 FOR INSPECTION EVAL AND REPAIR. FIBEROPTIC CABLE 01-350 WAS FOUND TO BE IN NEW CONDITION WITH VERY LITTLE SIGNS OF WEAR. THE 08-0070 DEEP PELVIC RETRACTOR WAS RECEIVED WELL USED, AND IN NEED OF SOME MAINTENANCE. THE FIBEROPTIC LIGHT CARRIER HAD SOME CONTAMINATION ON BOTH THE DISTAL AND PROXIMAL ENDS AS A RESULT OF AGE, USE AND CONTINUED STERILIZATION. LIGHT TRANSMISSION THROUGH THE RETRACTOR, ALTHOUGH DIMINISHED WAS APPROX 80 PERCENT CAPACITY. OUR RECORDS AND THE LACK OF SERIAL NUMBERS ON THIS INSTRUMENT INDICATE THAT IT HAS NOT BEEN RETURNED TO ESI FOR MAINTENANCE SINCE NEW. THE USER FACILITY HAS MANY OF THESE RETRACTORS AND IS AWARE OF THE WARNINGS REGARDING THE USE OF XENON LIGHT SOURCES THAT ARE LABELED WITH EACH SHIPMENT AS PART OF ESI CARE AND CLEANING. THIS INFO IS ALSO AVAILABLE VIA OUR WEBSITE. INITIAL REPORTER VERIFIED THAT THE CARE AND CLEANING AS WELL AS THE SUBSEQUENT WARNING IS ON FILE AT THE FACILITY. WE EXPECT TO REPLACE THE FIBEROPTIC LIGHT CARRIER ON THE 08-0070 RETRACTOR, AND REFURBISH THE RETRACTOR TO NEW CONDITION AS WELL AS ASSIGN A SERIAL NUMBER WITH CURRENT INSTRUMENT MARKING PROCEDURES AND HISTORY DOCUMENTATION. BOTH THE 08-0070 RETRACTOR AND 01-0350 CABLE WILL THEN BE RETURNED TO SERVICE.

    Description of Event or Problem · 1

    PT WAS IN SURGERY FOR ABDOMINOPLASTY AND MASTOPLASTY. CASE BEGAN AT 9:30 A.M. WHEN RELIEVING SCRUB NURSE BEGAN APPROX 12:00 NOON, HE/SHE ASKED THE INITIAL SCRUB NURSE WHERE BLISTERS ON THE PT'S LEFT BREAST CAME FROM. INITIAL REPORT FURTHER STATED THAT THE PT WAS SUBJECT TO BLISTERING ON THE LATERAL ASPECT OF THE LEFT BREAST, AND THAT THE FIBEROPTIC REFRACTOR MAY HAVE BEEN PLACED ON THE PT DURING THE PROCEDURE. INSTRUMENTATION INCLUDED A BFW XI 300 LIGHT SOURCE, AND ESI 01-0350 FIBEROPTIC CABLE CONNECTED TO AN ESI 08-0070 DEEP PELVIC RETRACTOR. INITIAL REPORTER ALSO STATED THAT THE DEVICES DID NOT MALFUNCTION OR BECOME DISCONNECTED DURING THE PROCEDURE. NO FURTHER DETAILS WERE GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30073 ELECTRO SURGICAL INSTRUMENT COMPANY FIBEROPTIC RETRACTOR FDG ELECTRO SURGICAL INSTRUMENT COMPANY 08-0070 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other SERIAL NUMBER 30-1724| ESI 01-0350 FIBEROPTIC CABLE| BFW XI 300 XENON LIGHT SOURCE: