BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG., AHTO IRRIGATION PUMP

    MDR report key: 9403724 · Received December 3, 2019

    Report

    Report Number
    0002936485-2019-00533
    Event Type
    Malfunction
    Date Received
    December 3, 2019
    Date of Event
    November 21, 2019
    Report Date
    March 3, 2020
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GCX
    UDI-DI
    07613327052138
    PMA / PMN Number
    K042454
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ALLEGED FAILURE: THE TOWER GENERATED A WARNING SIGNAL ON THE ISULATION MONITOR, WHICH WAS NOT RECOGNIZED BY THE RESPONSIBLE SISTER, BECAUSE SHE WAS NOT INSTRUCTED IN THESE SIGNALS ACCORDING TO HER OWN STATEMENT. SHORTLY AFTER THE SIGNAL, A JET OF FLAME OCCURRED AT THE AHTO (APPROX. 10-30 SECONDS), CAUSING THE POWER CABLE AND PUMP TO FUSE. THE INCIDENT DID NOT INFLUENCE THE SURGICAL RESULT, AS THE INCIDENT TOOK PLACE BEFORE THE BEGINNING OF THE SURGERY (THE PATIENT HAD JUST BEEN PUSHED INTO THE ROOM). SURGICAL DELAY OF 15MIN. NOT LONGER. THERE HAVE BEEN NO CHANGES IN THE PROCEDURE OF THE SURGERY. NOBODY WAS INJURED OR IMPAIRED. PLEASE SEE THE FOLLOWING COMPOMENTS WHICH BELONG TO THE TOWER AFFECTED IN THIS EVENT: REF 250-070-601 SN: (B)(4). COMPUTER SDC-HD-REF 240-050-888 SN: (B)(4). TRANSMITTER SYNK WIRELESS SYSTEM SN: (B)(4). LIGHT SOURCE X8000 SN: (B)(4). PRINTER SDP1000 SN: (B)(4). MONITOR, TFT VISIONELECT HD SN: (B)(4). INSUFFLATOR 40 LITER SN: (B)(4). CAMERA PROCESSOR 1188HD SN: (B)(4). CAMERA HEAD 1188210105 SN: (B)(4). THE FAILURE(S) IDENTIFIED IN THE INVESTIGATION IS CONSISTENT WITH THE COMPLAINT RECORD. PROBABLE ROOT CAUSES COULD BE THE PUMP'S AC INLET GOT SOME FLUID INGRESS (EX. SALINE, CLEANING CHEMICAL) CAUSING SHORT CIRCUIT ON THE AC INLET. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201959 PKG., AHTO IRRIGATION PUMP APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED GCX STRYKER ENDOSCOPY-SAN JOSE 0250070601 07613327052138

    Patients

    Seq Age Sex Outcome Treatment
    1