BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIRANHA

    MDR report key: 12962738 · Received December 8, 2021

    Report

    Report Number
    1418479-2021-00053
    Event Type
    Malfunction
    Date Received
    December 8, 2021
    Report Date
    May 19, 2022
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    JCX
    UDI-DI
    04055207011874
    PMA / PMN Number
    K041610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP REPORT #1 IS TO PROVIDE FDA WITH CORRECTED AND NEW INFORMATION. THE RESULTS OF THE DEVICE INVESTIGATION: ACCORDING TO THE MANUFACTURER, THE DEVICE WAS TESTED USING VISUAL AND FUNCTIONAL MEANS. THE SUCTION PUMP 2208.011 WAS TESTED ACCORDING TO THE WORK INSTRUCTION AAW03-098-0630, ALSO IN COMBINATION OF THE DEVICES FROM RWMIC COMPLAINT (B)(4) AND C (FOOTSWITCH). ACCORDING TO THE CHANGE FORM PK21-0013, THE GAP DIMENSION OF THE VALVE MEETS THE SPECIFICATION. HOWEVER, THE DOUBLE SILENCER IS CHARRED DUE TO LEAKAGE. THE LEAKAGE CAN BE BETWEEN SUCTION PUMP AND ANY OTHER PERIPHERY DEVICES SUCH AS HAND PIECE, TUBING OR CONTAINER. THE USER IS ADVISED IN THE RELATED IFU GA-A-252-USA/EN/2012-07 V2.0/PDG 11-5360 TO CHECK THE ENTIRE SYSTEM BEFORE EACH USE. PROBABLE ROOT CAUSE: USER ERROR, OTHER - SEE FINDINGS. REPORTED CONDITION CONFIRMED: YES. DEVICE MEETS SPECIFICATIONS: NO. PRODUCT DISPOSITION: REPAIR. INVESTIGATION FOR THE CONCOMITANT DEVICES IN THIS PIRANHA SYSTEM THAT WERE SENT IN: THE INVESTIGATION CONCLUDED THAT THE FOOTSWITCH (2030108): "THE FOOT SWITCH 2030.108 WAS TESTED ACCORDING TO THE WORK INSTRUCTION AAW03-098-0630, ALSO IN COMBINATION OF THE DEVICES FROM RWMIC COMPLAINT (B)(4) (CONTROLLER) AND B (SUCTION PUMP). NO DEVICE PROBLEM OF THE FOOTSWITCH WAS FOUND. THE REPORTED ISSUES WAS CAUSED BY THE SUCTION PUMP (DEVICE ALSO IN COMPLAINT (B)(4)), ROOT CAUSE: NO DEVICE PROBLEM FOUND REPORTED CONDITION CONFIRMED: NO DEVICE MEETS SPECIFICATIONS: YES DISPOSITION: RETURNED THE DEVICE TO THE CUSTOMER THE INVESTIGATION CONCLUDED THAT THE CONTROLLER (2303.011): "THE MOTOR CONTROL UNIT (2303.011) WAS TESTED ACCORDING TO THE WORK INSTRUCTION AAW03-098-0630, ALSO IN COMBINATION OF THE DEVICES FROM (B)(4) SUCTION PUMP AND FOOTSWITCH. NO DEVICE PROBLEM OF THE MOTOR CONTROL UNIT WAS FOUND, THE REPORTED ISSUE WAS CAUSED BY THE DEVICE FROM (B)(4) (SUCTION PUMP), SEE DETAILS ABOVE ROOT CAUSE: NO DEVICE PROBLEM FOUND. REPORTED CONDITION CONFIRMED: NO. DEVICE MEETS SPECIFICATIONS: YES. DISPOSITION: RETURNED THE DEVICE TO THE CUSTOMER.

    Additional Manufacturer Narrative · 0

    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 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 · 0

    THE PURPOSE OF THIS SUBMISSION IS TO REPORT THE RESULTS OF THE DEVICE INVESTIGATION AND CORRECT THE PRODUCT AND SERIAL NUMBER. IN THE INITIAL REPORT, IT WAS THOUGHT THAT THE CONTROLLER WAS THE ISSUE. AFTER THE DEVICE INVESTIGATION, IT WAS DETERMINED THAT THE PIRANHA SUCTION PUMP WAS THE SOURCE OF THE DEVICE MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO RICHARD WOLF BY THE USER FACILITY THAT "DURING THE CASE THE CONTROLLER STOPPED WORKING. THE SETTING WAS ON 2, AND THE PHYSICIAN WANTED TO CHANGE IT TO 1. THE LANGUAGE HAD PREVIOUSLY CHANGED TO GERMAN, AND WHEN THEY TRIED TO CHANGE THE SETTING, THE SETTINGS WENT TO 4, AND THE KEYS WOULD NOT WORK. WITH THE SETTING ON 4, THE PHYSICIAN DETERMINED THAT IT WAS UNSAFE TO CONTINUE USING IT. THERE WAS NO INJURY CAUSED BY THE MACHINE MALFUNCTION, BUT ALTERNATE MEANS WERE NEEDED TO COMPLETE THE CASE." ADDITIONAL DETAILS: 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? YES. OTHER DEVICES SENT IN WITH THE CONTROLLER IS THE SUCTION PUMP AND FOOTSWITCH (LISTED UNDER CONCOMITANT DEVICES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1858091 PIRANHA SUCTION PUMP JCX RICHARD WOLF GMBH 2208011 04055207011874
    1858092 PIRANHA SUCTION PUMP JCX RICHARD WOLF GMBH 2208011 04055207011874

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown FOOTSWITCH.(B)(6).| PIRANHA SUCTION PUMP.(B)(6).