PIRANHA
Report
- Report Number
- 1418479-2022-00022
- Event Type
- Injury
- Date Received
- August 2, 2022
- Date of Event
- June 29, 2022
- Report Date
- September 23, 2022
- Manufacturer
- RICHARD WOLF GMBH
- Product Code
- JCX
- UDI-DI
- 04055207011874
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- IN, US
- Reporter Occupation
- 003
Narratives
RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION IS THE IMPORTER OF THIS DEVICE. RWMIC IS SUBMITTING THIS REPORT ON BEHALF OF RICHARD WOLF GMBH (MANUFACTURER). 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.
FOLLOW-UP REPORT #1 IS TO PROVIDE FDA WITH THE RESULTS OF THE DEVICE INVESTIGATION ABOUT THIS MDR. PATIENT INFORMATION: THE SALES REPRESENTATIVE WAS CONTACTED ON 8/12/2022 IN AN EFFORT TO COLLECT PATIENT INFORMATION. ON 8/15/2022, THE SALES REPRESENTATIVE CONFIRMED NO FURTHER INFORMATION CAN BE PROVIDED. THE RESULTS OF THE DEVICE INVESTIGATION: RWGMBH INVESTIGATION REPORT DEVICE EVALUATION, FORM 5020 (12), DATE: 9/7/2022. THE DEVICE HAS BEEN INSPECTED VISUALLY AND TESTED FUNCTIONALLY. THE REPORTED CONDITION WAS NOT CONFIRMED AND THE DEVICE DID NOT MEET SPECIFICATIONS. THE DEVICE WAS INVESTIGATED IN THE RESPONSIBLE DEPARTMENT. THE DEVICE WAS ALSO CHECKED TOGETHER WITH THE CONCOMITANT DEVICES. NO PRODUCT PROBLEM WAS FOUND. DUE TO REPAIR THE 0-RING SHALL BE REPLACED, BUT THIS REPLACEMENT IS NOT CONNECTED TO THE REPORTED ISSUE. THE GAP DIMENSION OF THE PINCH VALVE MEETS THE SPECIFICATIONS, BUT ACCORDING TO THE CHANGE FORM PK2L -0013, IT NEEDS TO BE REPLACED. PRODUCT DISPOSITION: RECOMMENDED REPAIR. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) CONSIDERS THIS MDR CLOSED. RWMIC WILL SUBMIT A FOLLOW UP REPORT WHEN NEW INFORMATION BECOMES AVAILABLE.
RWMIC REFERENCE COMPLAINT NO. (B)(4). IT WAS REPORTED TO RICHARD WOLF MEDICAL INSTRUMENTS CORP. (RWMIC) BY A SALES REPRESENTATIVE/RWMIC THAT THE "PINCH VALVE WAS HEATING UP DURING A PROCEDURE AND HAD AN EXTREMELY SLOW MORCELLATION RATE." ADDITIONAL INFORMATION REPORTED BY THE SALES REPRESENTATIVE: (07/13/2022). 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? UNKNOWN. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES. FOLLOW-UP QUESTIONNAIRE'S RESPONSE PROVIDED BY THE SALES REPRESENTATIVE: (07/18/2022). HOW LONG WAS THE PROCEDURE DELAYED? APPROXIMATELY 1HOUR. WHAT ACTIONS WERE BEING DONE DURING THE DELAY? IT WAS WORKING, ALTHOUGH VERY SLOWLY, SO NO CHANGES WERE MADE AND CONTINUED IN PROCEDURE WITH EQUIPMENT THEY HAD. DID THE PATIENT REQUIRE ANY ADDITIONAL TREATMENT DURING THE DELAY OR WILL REQUIRE ANOTHER PROCEDURE AS THE RESULT OF THE DELAY? NO ADDITIONAL TREATMENTS OR PROCEDURES WERE INDICATED. WHAT WAS THE PATIENT'S OUTCOME? THE PROCEDURE WAS CONCLUDED WITH EXPECTED RESULTS, NO OUTCOMES WERE REPORTED TO HAVE BEEN ALTERED DUE TO DELAY. RWMIC MDR AWARENESS DATE: 18-JULY-2022.
RWMIC REFERENCE COMPLAINT NO. (B)(4). THE PURPOSE OF THIS SUBMISSION IS TO REPORT THE RESULTS OF THE DEVICE EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2032666 | PIRANHA | SUCTION PUMP | JCX | RICHARD WOLF GMBH | 2208011 | 04055207011874 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other| R | 2030108 - FOOTSWITCH 1 PEDALSN (B)(6)| 2303.011-MOTOR CONTROL UNIT 2303SN (B)(6)| 8564.021 - MOTOR HANDPIECESN (B)(6)| 8564.021 - MOTOR HANDPIECESN (B)(6)| 8564.021 - MOTOR HANDPIECESN (B)(6)| 8564.021 - MOTOR HANDPIECESN (B)(6)| 8564.021 - MOTOR HANDPIECESN (B)(6) |