BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIRANHA

    MDR report key: 11582361 · Received March 29, 2021

    Report

    Report Number
    1418479-2021-00006
    Event Type
    Malfunction
    Date Received
    March 29, 2021
    Date of Event
    March 5, 2021
    Report Date
    November 16, 2021
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    JCX
    UDI-DI
    04055207011874
    PMA / PMN Number
    K041610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RWMIC IS SUBMITTING THIS REPORT ON BEHALF OF RICHARD WOLF GMBH. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION IS THE IMPORTER OF THIS DEVICE. FOLLOW-UP REPORT #1 IS TO PROVIDE FDA WITH MISSING INFORMATION, NEW INFORMATION, AND CHANGED INFORMATION. MISSING INFORMATION: USER FACILITY WAS BEEN CONTACTED TWICE FOR ADDITIONAL INFORMATION; AS OF 11/23/21 WE'VE NOT RECEIVED A RESPONSE. RWMIC CONSIDERS THIS MDR CLOSED. SHOULD WE RECEIVE NEW INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THE DEVICE INVESTIGATION REPORT: RW GMBH RECEIVED AND BOTH VISUALLY AND FUNCTIONALLY EVALUATED THE DEVICE. ACCORDING TO THE MANUFACTURER, THE REPORTED CONDITION WAS CONFIRMED. ACCORDING TO THE INVESTIGATION REPORT FROM THE MANUFACTURER: "THE SUCTION PUMP (2208.11) WAS TESTED ACCORDING TO THE WORK INSTRUCTION AAW03-098-0630. ACCORDING TO THE CHANGE FORM PK21-0013. THE GAP DIMENSION OF THE VALVE MEETS THE SPECIFICATION. HOWEVER, THE COMPRESSOR DOES NOT REACH THE REQUIRED VACUUM. THE DEVICE WAS COMPLETELY DISASSEMBLED, NO RESIDUES OF ASPIRATED LIQUID OR ANY OTHER DAMAGES WERE DETECTED." FOR CLARIFICATION, SOME ADDITIONAL DETAILS ABOUT THE INVESTIGATION: THEY HAVE TESTED THE DEVICE AND THE COMPRESSOR COULD NOT REACH THE REQUIRED VACUUM. TO IDENTIFY THIS ISSUE, THEY DISASSEMBLED THE DEVICE COMPLETELY, BUT THEY DID NOT FIND ANYTHING WHICH COULD EXPLAIN THE FAILURE OF THE COMPRESSOR. AS FOR THE REPAIR, THEY WOULD REPLACE THE COMPRESSOR AND REPAIR-RELATED SET AND ADJUST THE DEVICE.

    Additional Manufacturer Narrative · 1

    RWMIC IS SUBMITTING THIS REPORT ON BEHALF OF RICHARD WOLF (B)(4). RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION IS THE IMPORTER OF THIS DEVICE. RWMIC CONSIDERS THIS MDR/COMPLAINT OPEN. RWMIC WILL SUBMIT A FOLLOW-UP REPORT AFTER THE DEVICE EVALUATION HAS BEEN COMPLETED AND/OR NEW INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ON MARCH 12, 2021 THE USER FACILITY REPORTED THE FOLLOWING TO RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) DURING A PROCEDURE ON (B)(6) 2021 "THAT A PUMP STOPPED CREATING SUCTION, DURING CASE, AND ISSUES COULD NOT BE RESOLVED." WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED ON A PATIENT WHEN THE REPORTING ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO THE PATIENT DUE TO THE REPORTED ISSUE? NO. WAS THERE ANY INJURY OR ILLNESS TO ANY OTHER PERSONNEL DUE TO THE REPORTED ISSUE? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED? YES. DID THE DELAY PUT THE PATIENT AT RISK? YES. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? NO. WAS THE SCHEDULED PROCEDURE COMPLETED? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478344 PIRANHA SUCTION PUMP JCX RICHARD WOLF GMBH 2208011 04055207011874

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown