BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIRANHA

    MDR report key: 12235365 · Received July 27, 2021

    Report

    Report Number
    1418479-2021-00034
    Event Type
    Malfunction
    Date Received
    July 27, 2021
    Date of Event
    July 19, 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
    NY, US
    Reporter Occupation
    NURSE
    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 #2 IS TO PROVIDE FDA WITH NEW INFORMATION, AND CHANGED INFORMATION. NEW INFORMATION: THE FOLLOWING FIELDS HAVE NEW INFORMATION: B5, H6, H10, H7 - 8. CHANGED INFORMATION: THE FOLLOWING FIELDS HAVE CHANGED INFORMATION: D9, H3. 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: CAUTION! FOR THERAPEUTICAL USE IT IS NECESSARY TO KEEP AN ADEQUATE REPLACEMENT UNIT AT HAND SHOULD THE DEVICE FAIL. FOLLOWING INSTRUCTIONS COULD HAVE BEEN APPLIED - IFU GA-A 252. SECTION 3.1.4 DESCRIPTION OF CONNECTIONS - "CONNECT THE OVERFLOW PROTECTION/BACTERIA FILTER... SECTION 4 CHECKS AS WELL AS SECTION 4.1 VISUAL CHECK - CHECK THE DEVICE AND ITS ACCESSORIES FOR DAMAGE, LOOSEN OR MISSING PART, HYGIENE AND COMPLETENESS BEFORE AND AFTER EACH USE. SECTION 5.6 USING THE DEVICE - THE PRODUCTS HAVE ONLY LIMITED STRENGTH. 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 THE DEVICE EVALUATION HAS BEEN COMPLETED AND/OR NEW INFORMATION BECOMES AVAILABLE. FOLLOW-UP REPORT #1 IS TO PROVIDE FDA WITH MISSING INFORMATION, NEW INFORMATION, AND CHANGED INFORMATION. SEE ALSO MDR 1418479-2021-00035.

    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 REPORTED CONDITION, SUCTIO PROBLEMS, WAS CONFIRMED. FINDINGS: THE "SUCTION PUMP WAS TESTED ACCORDING TO THE WORK INSTRUCTION AA W03-098-0630, ALSO IN COMBINATION OF THE DEVICE FROM CMPT 21-00261 A (MDR 1418479-2021-00034), THE SUCTION PUMP HAD TO BE COMPLETELY DISASSEMBLED. A SMALL PIECE OF SILICONE TUBE WAS FOUND INSIDE THE SUCTION PUMP WHICH BLOCKED THE SUCTION PUMP. AFTER RETRIEVING THE PIECE AND ASSEMBLING THE SUCTION PUMP, IT WORKS PROPERLY. ACCORDING TO THE PK21-0013, THE GAP DIMENSION OF THE VALVE MEETS THE SPECIFICATION, NO FURTHER ACTIONS REQUIRED. TEST METHOD: VISUAL AND FUNCTIONAL. PROBABLE ROOT CAUSE: USER ERROR. DISPOSITION: REPAIR. ADDITIONAL FOLLOW-UP ABOUT THIS DEVICE: QUESTION SENT TO THE MANUFACTURER ABOUT DEVICE EVALUATION. IS THIS SOMETHING THAT THE USER FACILITY MIGHT HAVE DISCOVERED (THE PIECE OF TUBING) THEMSELVES OR WAS IT NECESSARY FOR THE DEVICE TO BE RETURNED TO RW FOR MAINTENANCE? COULD HAVE EXPELLED IT BY FOLLOWING DIRECTIONS (IF SO WHICH ONES) IN THE IFU? RESPONSE: "UNFORTUNATELY, HE HAS NEVER SEEN ANYTHING SIMILAR TO THIS CASE. HE HAS ASSUMED THAT THEY HAVE FORGOTTEN THE FILTER, BUT HOW LONG THE PIECE OF THE SILICON TUBE WAS IN THE PUMP IS UNCLEAR. HOWEVER, THE USER FACILITY STATED THAT THE PUMP WAS WORKING PROPERLY TILL THEY CHANGED TO THE 4TH CANISTER. THIS INFORMATION INDICATES THAT THE PIECE IS FROM ONE OF THE SILICON TUBES USED DURING THE REPORTED PROCEDURE. PLEASE ALSO SEE ATTACHED THE IMAGES OF THE FOUND PIECE OF SILICON TUBE. IT SEEMS QUITE "NEW". THE PIECE WAS LARGE ENOUGH TO SEE THAT A PART OF THE SILICON TUBE IS MISSING. FOLLOWING INSTRUCTIONS COULD HAVE BEEN APPLIED - IFU GA-A 252-USA / EN / 2012-07 V2.0 / PDG 11-5360. SECTION 3.1.4 DESCRIPTION OF CONNECTIONS "CONNECT THE OVERFLOW PROTECTION/BACTERIA FILTER". SECTION 4 CHECKS AS WELL AS SECTION 4.1 VISUAL CHECK [?] CHECK THE DEVICE AND ITS ACCESSORIES FOR DAMAGE, LOOSEN OR MISSING PART, HYGIENE AND COMPLETENESS BEFORE AND AFTER EACH USE. SECTION 5.6 USING THE DEVICE [?] THE PRODUCTS HAVE ONLY LIMITED STRENGTH.

    Description of Event or Problem · 0

    THE PURPOSE OF THIS REPORT IS TO ADD PATIENT AND OTHER INFORMATION RECEIVED FROM THE USER FACILITY AS PART OF DUE DILIGENCE. ACCORDING THE USER FACILITY, THE DOCTOR WAS PERFORMING A LASER ENUCLEATION OF PROSTATE WITH MORCELLATION. THE DEVICE WAS SET TO THREE WHEN SUCTION CONTROL FAILED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 RW BY THE USER FACILITY THAT: THE PUMP WAS IN USE AND AFTER THEY CHANGED TO THE 4TH CANISTER THE MACHINE WOULD GO BACK TO TREATMENT MODE AND THEN SAY CHECK FOR LEAKS OR PRESSURE WASN'T RIGHT. THEY CHANGED THE TUBING, FILTER, CANISTER, MOTOR AND BLADE BUT NOTHING SEEMED TO CORRECT IT. THEY ARE HOPING TO BRING THE PATIENTS BACK TOMORROW TO GET THE REST OF THE TISSUE OUT IF WE CAN GET THEM THE LOANERS. ADDITIONAL INFORMATION: 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? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131436 PIRANHA SUCTION PUMP JCX RICHARD WOLF GMBH 2208011 04055207011874

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Other MOTOR CONTROL UNIT, 2303011