PIRANHA
Report
- Report Number
- 1418479-2021-00061
- Event Type
- Injury
- Date Received
- January 5, 2022
- Date of Event
- December 10, 2021
- Report Date
- May 2, 2022
- Manufacturer
- RICHARD WOLF GMBH
- Product Code
- JCX
- UDI-DI
- 04055207011874
- PMA / PMN Number
- K041610
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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 CORRECTED INFORMATION. THE PREVIOUSLY SUBMITTED MDR (FU 2) WAS MISSING PART OF THE PRODUCT HISTORY EVALUATION. CORRECTED/CHANGED INFORMATION: THE FOLLOWING FIELDS HAVE CHANGED INFORMATION: H10. THE REPORTED SUCTION PUMP 2208.011 WITH THE SERIAL NUMBER (B)(6) WAS PRODUCTED ON 09/07/2018 AND IT WAS DELIVERED TO RWMIC ON 10/01/2018. ACCORDING TO THE RECORDS, THE SUCTION PUMP WAS DELIVERED TO THE USER ON (B)(6) 2018. THERE ARE NO FURTHER RECORDS ABOUT MAINTENANCE, REPAIR OR COMPLAINT REGARDING THIS SUCTION PUMP IN THE DATABASE OF RWGMBH. THE USER IS ADVISED IN THE IFU GA-A 252-USA / EN / 2012-07 V2.0 / PDG 11-5360 TO SERVICE THE SUCTION PUMP AT LEAST ONCE A YEAR TO AVOID ANY INCIDENTS OR DAMAGE CAUSED BY AGING AND WEAR. SINCE THE REPORTED SUCTION PUMP WILL NOT BE RETURNED FOR INVESTIGATION, THE ROOT CAUSE COULD NOT BE DETERMINED. RWGMBH HAS RECEIVED 31 COMPLAINTS INCLUDING THE CURRENT COMPLAINT (22-00412A) REGARDING THE SUCTION PUMP 2208.011 BETWEEN (B)(6) 2019 AND (B)(6) 2022. THERE ARE 3 COMPLAINTS WHERE THE DEVICE WILL NOT RETURNED FOR INVESTIGATION, SO A ROOT CAUSE COULD NOT BE DETERMINED: 21-00321 / 700016861 21-00412A / 700017423 - CURRENT COMPLAINT 21-00413A / 700017424 THERE WERE 12 COMPLAINTS WHERE NO DEVICE PROBLEM WAS FOUND: 19-00183 / 700012787 19-00207B / 700012813 19-00377 / 700013638 19-00430B / 700013929 21-00025B / 700016464 21-00008 / 700015721 21-00031 / 700015857 21-00077A / 700016498 21-00076A / 700016500 21-00227A / 700016624 21-00330A / 700016862 21-00401 / 700017339 SINCE THE SUCTION PUMP IS USED IN A SYSTEM, IN MANY CASES THE MALFUNCTION OR LOSS OF SUCTION COULD BE CAUSED BY ONE OF THE PERIPHERY DEVICE. IF THESE DEVICES ARE NOT RETURNED, THE ROOT CAUSE OF THE CASE CANNOT BE DETERMINE. THERE WERE 8 COMPLAINTS WHERE THE PINCH VALVE WAS OUT OF SPECIFICATIONS, THIS MALFUNCTION WAS CORRECTED BY THE CHANGE PK21-0013: 19-00304A / 700013369 20-00325 / 700015551 21-00005A / 700015790 21-00024A / 700015908 21-00078 / 700016460 21-00045 / 700016459 21-00202A / 700016462 21-00220 / 700016463 THERE WAS 2 COMPLAINT WHERE RWGMBH HAS RECEIVED, BUT NOT LISTED IN THE TREND REPORT FROM RWMIC: 18-00469 / 700011760 - NO DEVICE PROBLEM WAS FOUND 19-00083A / 700012122 - CONNECTION AT THE DOUBLE SILENCER BROKEN OFF, THUS NO PRESSURE BUILD-UP CAUSED BY INCORRECT HANDLING. THE FOLLOWING 4 COMPLAINTS HAD VARIOUS DAMAGES DUE TO HANDLING: 19-00353B / 700013623 - DOUBLE SILENCER HAS DEFORMED 21-00176 / 700016461 - DOUBLE SILENCER WAS CHARRED DUE TO LEAKAGE 21-00261B / 700016585 - A SMALL PIECE OF A SILICON TUBE WAS FOUND INSIDE THE SUCTION PUMP 21-00361 / 700017211 - DOUBLE SILENCER HAS DEFORMED AND THE PINCH VALVE WAS SOILED DUE TO LEAKAGE THE FOLLOWING 2 COMPLAINTS HAD SPORADIC FAILURE: 21-00089 / 700016257 - COMPRESSOR DOES NOT REACH THE REQUIRED VACUUM, ROOT CAUSE WAS NOT FOUND 21-00108 / 700016258 - SWITCHING POWER SUPPLY HAS A SHORT CIRCUIT. RW GMBH HAS NO INFORMATION ABOUT THE FOLLOWING 8 COMPLAINTS WHICH ARE LISTED IN TREND REPORT FROM RWMIC: 19-00026 19-00064 / 19-00077 21-00043A 21-00058A 21-00067 21-00070 21-00103A 21-00109 IF THESE COMPLAINTS WERE RETURNED TO RWGMBH AS REPAIR, THEY WERE NOT RECORDED IN THE COMPLAINT DATABASE. THE FOLLOWING 6 COMPLAINTS FROM THE TREND REPORT WERE RECORDED IN CONNECTION WITH DIFFERENT DEVICES AT RWGMBH, SINCE NO ISSUES/MALFUNCTIONS WAS FOUND WITH THE SUCTION PUMP OR THE REPORTED ISSUE IS RELATED RATHER TO THE OTHER DEVICE: 20-00079B: 20-00079A / 700014397 20-00114C: 20-00114A / 700014519 20-00231A: 20-00239B / 700015244 20-00239A: 20-00239B / 700015244 20-00264A: 20-00264B / 700015298 21-00399B: 21-00399A / 700017323 - INVESTIGATION IS PENDING, DEVICE HAS NOT BEEN RECEIVED. RWMIC CONSIDERS THIS MDR CLOSED. SHOULD RW RECEIVE NEW INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
(B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF RICHARD WOLF GMBH. (B)(4) IS THE IMPORTER OF THIS DEVICE. (B)(4) CONSIDERS THIS MDR OPEN. (B)(4) WILL SUBMIT A FOLLOW UP REPORT AFTER REVIEW OF THE PRODUCT/DEVICE HISTORY HAS BEEN COMPLETED AND/OR NEW INFORMATION BECOMES AVAILABLE.
FOLLOW-UP REPORT #1 IS TO PROVIDE FDA WITH RESULTS OF THE DEVICE HISTORY EVALUATION ALONG WITH ANY MISSING INFORMATION, NEW INFORMATION, AND CHANGED INFORMATION. MISSING INFORMATION: USER FACILITY WAS CONTACTED 3 TIMES IN AN EFFORT TO COLLECT PATIENT INFORMATION AND USER INFORMATION. AS OF 3/28/2022, RWMIC HAS NOT RECEIVED A RESPONSE. NEW INFORMATION: THE FOLLOWING FIELDS HAVE NEW INFORMATION: CHANGED INFORMATION: THE FOLLOWING FIELDS HAVE CHANGED INFORMATION: RWMIC IS SUBMITTING THIS REPORT ON BEHALF OF RICHARD WOLF GMBH. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION IS THE IMPORTER OF THIS DEVICE. RESULTS OF THE DEVICE HISOTRY EVALUATION: IT WAS REPORTED BY THE MANUFACTURER, RW GMBH, THAT: THE REPORTED SUCTION PUMP 2208.011 WITH THE SERIAL NUMBER (B)(6) WAS PRODUCTED ON 09/07/2018 AND IT WAS DELIVERED TO RWMIC ON 10/01/2018. ACCORDING TO THE RECORDS, THE SUCTION PUMP WAS DELIVERED TO THE USER ON (B)(6) 2018. THERE ARE NO FURTHER RECORDS ABOUT MAINTAINCE, REPAIR OR COMPLAINT REGARDING THIS SUCTION PUMP. THE USER IS ADVISED IN THE IFU GA-A 252-USA / EN / 2012-07 V2.0 / PDG 11-5360 TO SERVICE THE SUCTION PUMP AT LEAST ONCE A YEAR TO AVOID ANY INCIDENTS OR DAMAGE CAUSED BY AGING AND WEAR. RICHARD WOLF GMBH HAS RECEIVED 31 COMPLAINTS INCLUDING THE CURRENT COMPLAINT (B)(4) REGARDING THE SUCTION PUMP 2208011 BETWEEN (B)(6) 2019 AND (B)(6) 2022. THERE WAS 1 COMPLAINT WHERE THE DEVICE WAS NOT RETURNED FOR INVESTIGATION: (B)(4). THERE WERE (B)(4) COMPLAINTS WHERE NO DEVICE PROBLEM WAS FOUND: (B)(4). ACCORDING TO THE TREND REPORT, THERE WERE (B)(4) COMPLAINTS IN TOTAL REGARDING THE SUCTION PUMP 2208011. HOWEVER, RW GMBH HAS NOT RECEIVED ANY INFORMATION ABOUT THE FOLLOWING COMPLAINTS, THEY WERE INVESTIGATED EXCLUSIVELY BY RWMIC: (B)(4). THE FOLLOWING COMPLAINTS WERE RECORDED IN CONNECTION WITH DIFFERENT DEVICES: (B)(4).
THE PURPOSE OF THIS REPORT IS TO PROVIDE THE FDA WITH INFORMATION THAT HAD BEEN LEFT OUT OF THE PREVIOUSLY SUBMITTED PRODUCT HISTORY EVALUATION (FU 1). SEE MANUFACTURERS NARRATIVE (H10).
IT WAS REPORTED TO RICHARD WOLF: THERE WAS A LACK OF ENGAGEMENT BETWEEN THE PIRANHA AND THE PROSTATE TISSUE. WHILE TRYING TO CAPTURE THE FREED PROSTATE TISSUE THE BLADDER WAS CAUGHT INSTEAD. WE TRIED A DIFFERENT HANDLE, PIRANHA MACHINE, BLADE, AND CANISTER AND EXPERIENCED THE SAME ISSUE A SECOND TIME. THE CASE WAS COMPLETED BUT DR. SLOAN HAD TO REMOVE THE REMAINING TISSUE WITH A GRASPER AND LENGTHY LASERING. NO REPAIRS TO THE BLADDER WERE MADE. A THIRD MACHINE AND TWO DIFFERENT HANDLES WERE USED ON THE NEXT TWO CASES WITH NO PROBLEMS. TRANSCRIPT OF VOICEMAIL LEFT BY SALES MANAGER: THE PERSON I'M WITH TODAY DR. (B)(6) HAD AN INJURY WHERE THERE WASN'T ENOUGH SUCTION COMING FROM THE MACHINE. SO IT WASN'T ENGAGING THE PROSTATE TISSUE AND IN ATTEMPTING TO GET THE PROSTATE TISSUE INTO/TO ENGAGE THE MORCELLATOR THERE WAS SOME BLADDER TISSUE THAT WAS CAPTURED INSTEAD. SO WE SWITCHED THE SCOPES, MACHINES, HANDLE, AND CANISTERS AND USED THE PIRANHA AGAIN. IT HAPPENED AGAIN, SAME THING, THERE WASN'T ENOUGH SUCTION TO ENGAGE THE PROSTRATE TISSUE AND IT GATHERED BLADDER TISSUE INSTEAD. SO IT CUT THAT PATIENT TWICE. I THINK I HAVE DISCOVERED WHAT THE PROBLEM IS: SPD DEPARTMENT BANGING PIRANHA HANDLE ON COUNTER TO GET PIECES OUT, THINK THAT MAY HAVE CRACKED MORCELLATOR TO GET ALL THE PIECES. USED TWO OF THEIR HANDLES ON TWO OTHER PATIENTS AND THEY WENT PERFECTLY FINE. THIS IS THE CASE THAT PAULA IS CONNECTED TO. WHILE TRYING TO CAPTURE THE FREED PROSTATE TISSUE THE BLADDER WAS CAUGHT INSTEAD. WE TRIED A DIFFERENT HANDLE, PIRANHA MACHINE, BLADE, AND CANISTER AND EXPERIENCED THE SAME ISSUE A SECOND TIME (SECOND CUT TO THE BLADDER). THE CASE WAS COMPLETED BUT DR. (B)(6) HAD TO REMOVE THE REMAINING TISSUE WITH A GRASPER AND LENGTHY LASERING. NO REPAIRS TO THE BLADDER WERE MADE. A THIRD MACHINE AND TWO DIFFERENT HANDLES WERE USED ON THE NEXT TWO CASES WITH NO PROBLEMS. ADDITIONAL INFORMATION PROVIDED BY THE USER FACILITY: WILL THE PIRANHA DEVICE BE RETURNED? NO, I DO NOT BELIEVE SO. IT WAS CHECKED OUT, LEAK TESTED AND MONITORED IN OUR FACILITY. WAS THERE ANY INJURY OR ILLNESS TO ANY OTHER PERSONNEL DUE TO THE REPORTED ISSUE? NO, NO OTHER PERSONNEL REPORTED AN INJURY. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED? YES, WE HAD TO RETRIEVE A NEW SYSTEM/CANISTER/HAND PIECE THEREFORE THE PHYSICIAN DID HAVE TO WAIT. WHAT ACTIONS WERE BEING TAKEN DURING THE DELAY?THE PHYSICIAN WAS ABLE TO WORK ON LASERING/CAUTERIZING THE PROSTATE. DID THE DELAY PUT THE PATIENT AT RISK? NO, I DON'T BELIEVE THE DELAY CAUSED A RISK TO THE PATIENT. HOW LONG WAS THE DELAY? 10 MINUTES APPROXIMATELY. WAS ANOTHER DEVICE NEEDED? YES, WE WERE ABLE TO USE ANOTHER WOLF PIRANHA SYSTEM FROM OUR UROLOGY STORAGE UNIT. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES, ANOTHER PIRANHA SYSTEM WAS AVAILABLE. WAS THE SCHEDULED PROCEDURE COMPLETED? YES, THE SCHEDULED PROCEDURE WAS COMPLETED.
PLEASE SEE MANUFACTURERS NARRATIVE FOR THE RESULTS OF THE PRODUCT HISTORY EVALUATION. THE DEVICE WAS NOT RETURNED TO RICHARD WOLF FOR INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 804866 | PIRANHA | SUCTION PUMP | JCX | RICHARD WOLF GMBH | 2208011 | 04055207011874 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other| O | MOTOR CONTROL UNIT 2303. |