SHARK
Received Dec 16, 2020
Report 1418479-2020-00048 · MDR key 11020631
Device
Generic name
Cutting Electrode Mono 24fr, Sterile, For Single Use
Manufacturer
Richard Wolf GmbhModel number
46782425Catalog number
46782425
Lot number
21002048
Product problems
- Material Rupture
- Manufacturing, Packaging or Shipping Problem
- Material Rupture
- Manufacturing, Packaging or Shipping Problem
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
FOLLOW-UP REPORT #1 IS TO PROVIDE FDA WITH MISSING INFORMATION, NEW INFORMATION, AND CHANGED INFORMATION. MISSING INFORMATION: THE USER FACILITY WAS CONTACTED THREE TIMES IN AN EFFORT TO COLLECT PATIENT AND OTHER MISSING INFORMATION. ON MARCH 30, 2021 WE RECEIVED A RESPONSE THAT NO FURTHER INFORMATION IS AVAILABLE. RESULTS OF THE DEVICE INVESTIGATION: THE DEVICE WAS VISUALLY AND FUNCTIONALLY EVALUATED AND FOUND TO HAVE A MANUFACTURING DEFECT WHICH WAS CAUSED BY 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 CLOSED HOWEVER SHOULD WE RECEIVE ADDITIONAL INFORMATION A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
FOR RESULTS OF THE DEVICE INVESTIGATION SEE THE MANUFACTURERS NARRATIVE.
Additional Manufacturer Narrative
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. RWMIC WILL REACH OUT TO USER FACILITY TO REQUEST ADDITIONAL INFORMATION.
Description of Event or Problem
ON NOVEMBER 12TH, 2020, THE USER FACILITY REPORTED THE FOLLOWING TO RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC): DR. (B)(6) HAD 4 MONOPOLAR ELECTRODES THAT LITERALLY BLEW UP IN A TURP CASE. WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED DURING A PROCEDURE WHEN THE ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO THE PATIENT DUE TO THE REPORTED ISSUE? UNKNOWN. 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? (ONLY APPLICABLE IF THERE WAS A REPORT OF DELAY) YES WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? NO.
Remedial action
- Replace