BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOROTOR® 3.2MM POWERED ENDOSCOPIC DEBRIDEMENT CATHETER - GASTROSCOPE OLYMPUS/P

    MDR report key: 18245773 · Received December 1, 2023

    Report

    Report Number
    3011697028-2023-00044
    Event Type
    Injury
    Date Received
    December 1, 2023
    Date of Event
    November 3, 2023
    Report Date
    November 29, 2023
    Manufacturer
    INTERSCOPE, INC.
    Product Code
    QNE
    UDI-DI
    00854172008193
    PMA / PMN Number
    DEN200016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ENDOROTOR WAS NOT RETURNED FOR INVESTIGATION. THE SOURCE OF THE BLEEDING WAS NOT CONFIRMED, THEREFORE NO ROOT CAUSE CAN BE DETERMINED. LHR WAS REVIEWED AND FOUND NO PROCESS DEVIATIONS NOR NONCONFORMANCES. THERE ARE NO OTHER COMPLAINTS RELATED THIS FAILURE MODE IN THIS LOT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6). 2023 A PANCREATIC NECROSECTOMY WAS PERFORMED ON A PATIENT. THIS WAS THE PATIENT'S 3RD DEBRIDEMENT USING THE ENDOROTOR DEVICE. THE PHYSICIAN STATED THAT ONCE THE THERAPEUTIC SCOPE WAS IN THE NECROTIC CAVITY, THE ENDOROTOR WAS PREPPED. NO OTHER CONVENTIONAL INSTRUMENTS WERE USED PRIOR TO THE USE OF THE ENDOROTOR CATHETER. AFTER ABOUT 15-20 MINUTES OF DEBRIDEMENT USING THE ENDOROTOR CATHETER, THE PHYSICIAN IMMEDIATELY RECOGNIZED SIGNIFICANT BLEED. THE CATHETER WAS QUICKLY REMOVED, AND THE PATIENT'S BLEEDING WAS TENDED TO. THE PATIENT DID NOT REQUIRE TREATMENT TO CONTROL THE BLEEDING AND THE SOURCE OF THE BLEEDING WAS NOT IDENTIFIED. THE BLEEDING CONTINUED FOR ABOUT 40 MINUTES AND THEN SUBSIDED. AFTER THE SCOPE WAS REMOVED, THE PATIENT WAS TRANSPORTED TO THE INTENSIVE CARE UNIT. THE PHYSICIAN STATED THERE WERE NO NOTICEABLE VESSELS AND/OR VISIBLE RISKS DURING THE DEBRIDEMENT. THE PHYSICIAN ADDED THAT THE PATIENT DID NOT HAVE ANY PANCREAS LEFT AND HE AND HIS TEAM WERE AWARE THAT THERE COULD BE VESSELS IN THE NECROTIC CAVITY. THE FOLLOWING MORNING, THE PHYSICIAN FOLLOWED UP AND STATED THAT THE PATIENT WAS STABLE. IT IS SUSPECTED THAT THE BLEEDING STEMMED FROM A "SMALL BRANCH OF SPLENIC VESSELS, PROBABLY VEIN; HOWEVER, THERE WAS NO KNOWN PSEUDOANEURYSM ON IMAGING AVAILABLE". ADDITIONAL INFORMATION WAS OBTAINED ON (B)(6). 2023, WHERE THE PHYSICIAN STATED THAT THE PATIENT REMAINED STABLE, AND NO FURTHER BLEEDING HAS BEEN NOTED. THE EVENT DID NOT REQUIRE ANY TREATMENT; HOWEVER, IT DID REQUIRE THE PATIENT TO BE ADMITTED. THE PHYSICIAN CONVEYED THAT THE ENDOROTOR WAS NOT A FACTOR IN THE BLEEDING AND THAT THE EVENT WAS RELATED TO THE PATIENTS' COMORBIDITIES. THERE WAS NO DEVICE FAILURE REPORTED AND NO ADDITIONAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1593827 ENDOROTOR® 3.2MM POWERED ENDOSCOPIC DEBRIDEMENT CATHETER - GASTROSCOPE OLYMPUS/P ENDOROTOR® 3.2MM PED CATHETER GASTRO QNE INTERSCOPE, INC. 3.2-PED-EGD-OP 230502B 00854172008193

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization