BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE 3-LUMEN EXTRACTION BALLOON V

    MDR report key: 10297659 · Received July 20, 2020

    Report

    Report Number
    8010047-2020-04619
    Event Type
    Malfunction
    Date Received
    July 20, 2020
    Date of Event
    June 23, 2020
    Report Date
    November 6, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    LQR
    UDI-DI
    04953170368721
    PMA / PMN Number
    K091495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT WAS SUBMITTED TO PROVIDE ADDITIONAL INFORMATION TO MDR# 8010047-2020-04619. THE ORIGINAL EQUIPMENT MANUFACTURER (OEM), PERFORMED A DEVICE HISTORY RECORD REVIEW AND NO ABNORMALITIES WERE NOTED. NO DEVICE WAS RETURNED TO THE OEM, HOWEVER, AN INVESTIGATION WAS COMPLETED BY THE OEM AND DETERMINED THAT THERE IS NO MANUFACTURING, MATERIAL OR PROCESSING RELATED CAUSE FOR THIS FAILURE MODE. BASED ON PREVIOUS COMPLAINTS, IT WAS SPECULATED THAT WHEN THE BALLOON WAS INFLATED AND QUARRYING, THE RUBBER OF THE BALLOON WAS DAMAGED AT THE CORNER OF THE STONE AND THE BALLOON RUPTURED. HOWEVER, IT WAS NOT POSSIBLE TO DETERMINE WHEN AND WHAT LOAD WAS APPLIED AND THE BALLOON WAS PUNCTURED. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE. AFTER CHECKING THE CONTENTS OF THE INSTRUCTION MANUAL, THE FOLLOWING CAUTION WAS ISSUED REGARDING THE DESCRIPTION RELATED TO THIS EVENT. - CONFIRM THAT THE BALLOON IS COMPLETELY DEFLATED WHEN INSERTING THE INSTRUMENT INTO THE ENDOSCOPE. IF THE BALLOON IS NOT DEFLATED COMPLETELY, THE DISTAL END OF THE INSTRUMENT MAY EXTEND FROM THE DISTAL END OF THE ENDOSCOPE ABRUPTLY. THIS COULD CAUSE PATIENT INJURY, SUCH AS PERFORATION, BLEEDING, OR MUCOUS MEMBRANE DAMAGE, AND COULD DAMAGE THE ENDOSCOPE AND/OR INSTRUMENT. - DO NOT FORCE TO INSERT THE INSTRUMENT IF RESISTANCE TO INSERTION IS ENCOUNTERED. REDUCE THE ANGULATION (OR LOWER THE FORCEPS ELEVATOR IF APPLICABLE) UNTIL THE INSTRUMENT PASSES SMOOTHLY. THE USE OF EXCESSIVE FORCE CAUSES PATIENT INJURY, SUCH AS PERFORATION, BLEEDING, OR MUCOUS MEMBRANE DAMAGE. IT MAY ALSO DAMAGE THE ENDOSCOPE AND/OR INSTRUMENT. - DO NOT ADVANCE OR EXTEND THE INSTRUMENT ABRUPTLY. THIS COULD CAUSE PATIENT INJURY, SUCH AS PERFORATION, BLEEDING, OR MUCOUS MEMBRANE DAMAGE. IT COULD ALSO DAMAGE THE ENDOSCOPE AND/OR INSTRUMENT. - INSERT THE INSTRUMENT INTO THE ENDOSCOPE SLOWLY. OTHERWISE, THE INSTRUMENT AND/OR THE ENDOSCOPE MAY BE DAMAGED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE USER¿S COMPLAINT WAS NOT CONFIRMED. THE USER FACILITY USED ONE BALLOON THAT POPPED WHEN TRYING TO USE IT ON A PATIENT. A DIFFERENT BALLOON OF THE SAME MODEL AND LOT WAS USED AND ACTIVATED WITHOUT IT RUPTURING. THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES. NO FINDINGS AVAILABLE. THE CAUSE COULD NOT BE DETERMINED. NO FURTHER INFORMATION WAS REPORTED. A SUPPLEMENTAL WILL BE SUBMITTED IF NEW INFORMATION BECOMES AVAILABLE OR THE DEVICE IS RETURNED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A BALLOON POPPED WHEN TRYING TO INFLATE IT DURING A PATIENT PROCEDURE. THERE WAS NO PATIENT INJURY OR HARM. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS FILE 3 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760485 SINGLE USE 3-LUMEN EXTRACTION BALLOON V SINGLE USE 3-LUMEN EXTRACTION BALLOON LQR OLYMPUS MEDICAL SYSTEMS CORP. B-V243Q-A 9ZV 04953170368721

    Patients

    Seq Age Sex Outcome Treatment
    1