BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE GRASPING FORCEPS(PARALLEL BASKET TYPE,3FR.)

    MDR report key: 11989737 · Received June 14, 2021

    Report

    Report Number
    8010047-2021-07467
    Event Type
    Injury
    Date Received
    June 14, 2021
    Date of Event
    May 20, 2021
    Report Date
    December 17, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    PTS
    PMA / PMN Number
    CLASS1-EXMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A SUPPLEMENTAL REPORT TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION, BECAUSE THE SUBJECT DEVICE WAS DISCARDED BY THE USER. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE MANUFACTURING RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. THIS EVENT HAS ALREADY OCCURRED IN THE PAST. BASED ON THE RESULT OF A PREVIOUS SIMILAR COMPLAINT INVESTIGATION, IT IS POSSIBLE TO PREDICT THE CAUSE OF THE REPORTED EVENT. THEREFORE, IT WAS DETERMINED THAT THE INVESTIGATION BY USING EQUIPMENTS OF SIMILAR STRUCTURE OR SIMILAR EQUIPMENTS WAS NOT NECESSARY. IT CAN BE INFERRED THAT THE TUBE MIGHT HAVE BEEN COMPRESSIVELY BUCKLED. THIS MIGHT HAVE CAUSED THE GRASPING PORTION NOT TO CLOSE. BASED ON THE SIMILAR INVESTIGATION RESULTS IN THE PAST, A LIKELY MECHANISM CAUSING THE REPORTED EVENT MIGHT BE THE FOLLOWING. 1. THE ENDOSCOPE WAS EXCESSIVELY ANGULATED. OR THE TUBE WHICH COMES OUT FROM THE ENDOSCOPE BIOPSY VALVE WAS BENT. 2. OPERATING THE RING IN THE ABOVE SITUATION HAVE CAUSED THE TUBE AND OPERATION WIRE TO INCREASE THE SLIDING RESISTANCE. THAT HAVE CAUSED THE TUBE COMPRESSIVELY BUCKLED. 3. DUE TO "2", THE OPERATING PORTION COULD NOT WORK WELL. REPEATEDLY OPERATING THE RING MIGHT HAVE MADE THE COMPRESSIVELY BUCKLED TUBE TO STRETCH AND TEAR. THE ABOVE DEVICE HANDLING HAS WARNED IN THE INSTRUCTION MANUAL AS FOLLOWS. *DO NOT COIL THE INSERTION PORTION WITH A DIAMETER OF LESS THAN 15 CM. THIS COULD DAMAGE THE INSERTION PORTION. *NEVER USE EXCESSIVE FORCE TO OPEN OR CLOSE THE GRASPING PORTION. THIS COULD DAMAGE THE INSTRUMENT.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO WITHDRAW MFR REPORT #8010047-2021-07467. OLYMPUS CONCLUDED THAT THERE WAS NO MDR REPORTABLE MALFUNCTION OR ADVERSE EVENT.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED, IF ADDITIONAL OR SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE HEALTH PROFESSIONAL THAT DURING THE PROCEDURE OF THE BRONCHUS USING THE SUBJECT DEVICE, THE FOLLOWING EVENT OCCURRED. THE DEVICE WAS NOT ABLE TO RETRACT INTO THE ENDOSCOPE. THE PATIENT HAD TO BE TRANSFERRED TO ANOTHER HOSPITAL. ON JUNE 1, 2021, THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED. *THE HEALTH PROFESSIONAL TRIED TO EXTRACT THE TOOTH IN THE BRONCHUS WITH THE DEVICE BUT IT FAILED, SO TRIED WITH ANOTHER DEVICE, BUT IT FAILED AGAIN. *THE PROCEDURE WAS EXTENDED BY 30 MINUTES. *IN THE TRANSFERRED HOSPITAL THE TOOTH WAS SUCCESSFULLY RETRIEVED FROM THE BRONCHUS. *THE PATIENT IS IN A GOOD GENERAL STATE OF HEALTH AFTER AN EXTENDED HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888682 DISPOSABLE GRASPING FORCEPS(PARALLEL BASKET TYPE,3FR.) DISPOSABLE GRASPING FORCEPS PTS OLYMPUS MEDICAL SYSTEMS CORP. FG-51D 03K

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown