BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIRANHA

    MDR report key: 12102062 · Received July 1, 2021

    Report

    Report Number
    1418479-2021-00029
    Event Type
    Malfunction
    Date Received
    July 1, 2021
    Report Date
    December 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
    FL, 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 #2 IS TO PROVIDE FDA WITH MISSING INFORMATION MISSING INFORMATION: THE SURGEON WAS CONTACTED TWO TIMES DIRECTLY AND THE USER FACILITY ONCE THROUGH THE SALES REP IN AN EFFORT TO COLLECT PATIENT INFORMATION AND USER INFORMATION. AS OF (B)(6) 20211, RWMIC HAS NOT RECEIVED A RESPONSE. NO REPORTED INJURY TO THE PATIENT; CONSIDERED LOW RISK. RWMIC CONSIDERS THIS MDR CLOSED. SHOULD RW RECEIVE NEW INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    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. RWMIC CONSIDERS THIS MDR/COMPLAINT OPEN. RWMIC WILL SUBMIT A FOLLOW UP REPORT AFTER CONTACTING THE USER FACILITY AND/OR NEW INFORMATION BECOMES AVAILABLE. FOLLOW-UP REPORT #1 IS TO PROVIDE FDA WITH MISSING INFORMATION, NEW INFORMATION, AND CHANGED INFORMATION. MISSING INFORMATION: THE SALES REP DOES NOT HAVE ANY ADDITIONAL INFORMATION TO REPORT. WE ARE ATTEMPTING TO CONTACT THE USER FACILITY IN AN EFFORT TO COLLECT PATIENT INFORMATION AND USER INFORMATION.

    Description of Event or Problem · 0

    SEE MANUFACTURERS NARRATIVE.

    Description of Event or Problem · 0

    THE PURPOSE OF THIS REPORT IS TO SHARE THE RESULTS OF THE DEVICE INVESTIGATION: IT WAS FOUND THAT THE PINCH VALVE DOES NOT OPEN TO SPECIFICATIONS >4.8MM; MEASURES 4.7MM. THE PINCH VALVE WAS REPLACED. PROBABLE ROOT CAUSE: MATERIAL FAILURE. REPORTED CONDITION WAS CONFIRMED, THE DEVICE WAS REPAIRED.

    Additional Manufacturer Narrative · 1

    RWMIC IS SUBMITTING THIS REPORT ON BEHALF OF RICHARD WOLF GMBH. 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, USER FACILITY HAS BEEN CONTACTED AND/OR NEW INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RICHARD WOLF BY THE SALES REP "HAVING SUCTION PROBLEMS". 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? 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
    997135 PIRANHA SUCTION PUMP JCX RICHARD WOLF GMBH 2208011 04055207011874

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown FOOT SWITCH PEDAL - 2030108