BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS EVIS EXERA GASTROVIDEOSCOPE

    MDR report key: 2507413 · Received March 9, 2012

    Report

    Report Number
    8010047-2012-00062
    Event Type
    Other
    Date Received
    March 9, 2012
    Date of Event
    December 20, 2011
    Report Date
    February 9, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GCK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADD'L INFO REGARDING THE REPORT AND WAS INFORMED THAT ON (B)(6) 2012 A FEMALE PT UNDERWENT A DIAGNOSTIC ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE DUE TO ABDOMINAL PAIN. THE PROCEDURE WENT WELL AND THE PROCEDURE WAS COMPLETED USING THE SAME GASTROSCOPE. HOWEVER, THE PT'S PRIMARY CARE PHYSICIAN (PCP) CONTACTED THE USER FACILITY IN (B)(6) 2012 AND INFORMED THEM THAT THE PT WAS DIAGNOSED WITH (B)(6) AFTER UNDERGOING THE EGD PROCEDURE. AS PART OF THE USER FACILITY'S INVESTIGATION INTO THIS MATTER THE GASTROSCOPE WAS TAKEN OUT OF SERVICE, AND THE INFECTION CONTROL OFFICERS HAVE BEEN INVOLVED WITH THE INVESTIGATION OF THEIR IV PROCESS, AND REPROCESSING OF THE ENDOSCOPE. THE STAFF REPORTED THAT THERE WAS NO DISCREPANCY OBSERVED IN ANY OF THESE PROCESSES, AS THEIR CLEANING PROCESS MEETS ALL THE CURRENT STANDARDS. THE USER FACILITY ALSO REPORTED THE SUBJECT GASTROSCOPE WAS USED ON 43 SUBSEQUENT PROCEDURES AND THERE WAS NO REPORTED COMPLICATIONS. THE USER FACILITY'S STAFF HAVE CONCLUDED THAT THERE WAS NO RELATIONSHIP BETWEEN THE PT'S (B)(6) WITH THE USE OF THE GASTROSCOPE. THE USER FACILITY AGREED TO RETURN THE DEVICE TO OLYMPUS FOR PHYSICAL EVAL, HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) WAS DISPATCHED TO ASSESS THE USER FACILITY'S REPROCESSING PRACTICES AND PROVIDE NECESSARY TRAINING AND EDUCATIONAL MATERIALS TO THE STAFF. THIS REPORT WILL BE SUPPLEMENTED IF SIGNIFICANT ADD'L INFO IS RECEIVED. THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A PHYSICIAN CONTACTED THEIR ORGANIZATION AND REPORTED THAT A PT HAD DEVELOPED (B)(6) FOLLOWING AN UNSPECIFIED EGD PROCEDURE AT THEIR FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA GASTROVIDEOSCOPE GASTROVIDEOSCOPE GCK OLYMPUS MEDICAL SYSTEMS CORPORATION GIF-160 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK