BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIRANHA

    MDR report key: 12001917 · Received June 15, 2021

    Report

    Report Number
    1418479-2021-00025
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Date of Event
    May 21, 2021
    Report Date
    December 8, 2021
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    JCX
    UDI-DI
    04055207011874
    PMA / PMN Number
    K041610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    003

    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 THROUGH THE SALES REP WAS CONTACTED IN AN EFFORT TO COLLECT PATIENT INFORMATION AND USER INFORMATION. RWMIC RECEIVED RESPONSE "NO FURTHER INFORMATION WAS AVAILABLE" DEVICE LABELING WAS REVIEWED FOR PATIENT CODE AND DEVICE CODES, SEE BELOW: - PATIENT CODE: NOT APPLICABLE, NO PATIENT PROBLEM WAS REPORTED. - DEVICE CODE: IFU WAS REVIEWED, FOR WHAT TO DO WHEN THERE IS NO OR INSUFFICIENT SUCTION FLOW (GA-A 252-USA / EN / 2012-07 V2.0 / PDG 11-5360 - SECTION 7.1 TROUBLESHOOTING). ' TUBES IMPROPERLY CONNECTED OR DEFECTIVE: CHECK TUBE CONNECTIONS FOR LEAKAGE AND CORRECT CONNECTION; REPLACE, IF NECESSARY. ' LID OF SECRETION CONTAINER LEAKING: CHECK LID OF SECRETION CONTAINER FOR LEAK TIGHTNESS AND REPLACE, IF NECESSARY. ' SILENCER CLOGGED: REPLACE SILENCER. ' TUBES KINKED OR CLOGGED: CHECK THE TUBES, CLEAN OR REPLACE, IF NECESSARY. ' SUCTION CHANNEL OF INSTRUMENT CLOGGED: CLEAN SUCTION CHANNEL, REPLACE IF NECESSARY. ' OVERFLOW PROTECTION / BACTERIA FILTER CLOGGED: CHANGE OVERFLOW PROTECTION / BACTERIA FILTER. RWMIC CONSIDERS THIS MDR CLOSED. SHOULD RW RECEIVE NEW INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THE PURPOSE OF THIS SUBMISSION IS TO REPORT THE RESULTS OF THE DEVICE INVESTIGATION. ACCORDING TO THE MANUFACTURER, "THE DEVICE WAS EVALUATED USING VISUAL AND FUNCTIONAL METHODS. THE SUCTION PUMP 2208.011 WAS TESTED ACCORDING TO THE WORK INSTRUCTION AAW03-098-0630. THE ISSUE WAS CAUSED BY A DOUBLE SILENCER WHICH WAS CHARRED DUE TO LEAKAGE. ACCORDING TO THE CHANGE FOR PK21-0013, THE GAP DIMENSION OF THE VALVE MEETS THE SPECIFICATION. NO CHANGE OF THE VALVE IS REQUIRED." ADDITIONAL DETAILS PROVIDED BY MANUFACTURER: USUALLY, THE CAUSE OF A THERMALLY DEFORMED DOUBLE SILENCER IS A LEAK IN THE VACUUM BUILD-UP DURING USE. IF THE TUBING ON THE HOSE SET, BACTERIA FILTER OR FLOAT VALVE IS LEAKING, THE SUCTION PUMP WILL OPERATE CONTINUOUSLY, SINCE THE REQUIRED VACUUM FOR AUTOMATIC SHUTDOWN IS NOT REACHED. THIS CONTINUOUS OPERATION OF THE PUMP LEADS TO OVERHEATING OF THE PUMP AND THE DOUBLE SILENCER IS THERMALLY DEFORMED. ACCORDING TO THE RECEIVED INFORMATION, THE USER FACILITY HAS USED THE DEVICE WITH THE DESCRIBED PROBLEM IN MULTIPLE PROCEDURES BEFORE SENDING THE DEVICE BACK. THIS INFORMATION INDICATES THAT THE DOUBLE SILENCER WAS UNDER THIS CONDITION FOR SEVERAL PROCEDURES BEFORE FAILING COMPLETELY. THERE ARE INSTRUCTIONS IN THE IFU WHAT TO DO WHEN THERE IS NO OR INSUFFICIENT SUCTION FLOW (GA-A 252-USA / EN / 2012-07 V2.0 / PDG 11-5360 - SECTION 7.1 TROUBLESHOOTING). SEE MANUFACTURERS NARRATIVE FOR ADDITIONAL INFORMATION. THERE WAS NO INFORMATION ABOUT IF THEY HAVE TRIED TO TAKE ANY ACTIONS TO SOLVE THE SUCTION PROBLEM. BASED ON THIS INFORMATION AND THE RESULT OF THE INVESTIGATION, THE PROBABLE ROOT CAUSE IS USER ERROR. IF THE USER FACILITY HAS FOLLOWED THE INSTRUCTIONS IN THE IFU TO CONNECT THE TUBING CORRECTLY AND ALSO CHECKING DURING PROCEDURE THE CORRECTNESS OF THE TUBING, THE DAMAGE OF DOUBLE SILENCER MAY HAVE NOT OCCURRED. THE DEVICE WAS REPAIRED.

    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

    IT WAS REPORTED TO RICHARD WOLF BY THE SALES REP THAT: PIRANHA SUCTION UNIT HAS BEEN LOSING SUCTION IN MULTIPLE PROCEDURES AND THE FACILITY WANT THEIR SYSTEM SENT IN FOR REPAIR. ADDITIONAL INFORMATION: DEVICE MALFUNCTION CAUSED A 10 TO 15 MINUTE DELAY IN PROCEDURE. NORMAL SURGICAL OUTCOME FOR PATIENT. NO RISK TO PATIENT. 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? NO. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? NO. WAS THE SCHEDULED PROCEDURE COMPLETED? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899580 PIRANHA SUCTION PUMP JCX RICHARD WOLF GMBH 2208011 04055207011874

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown