MAUDE Adverse Event Report: RICHARD WOLF GMBH SHARK; INTERNAL SHEATH RESECTOSCOPE 24FR

Model Number	8675324
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Rwmic is submitting this report on behalf of the manufacturer richard wolf gmbh.Device evaluation and inspection was performed by rwmic on 05-july-2022.Device investigation results provided: rwmic investigation report device evaluation, form 5020 (12).The device was tested visually.The reported condition was confirmed and the device did not meet specifications.The evaluation found that the damage is consistent with an impact against a hard surface.Damage may have caused a thin fracture that help together until there was stress on the device during use of breaking apart immediately.The device was repaired.Additional information regarding device labeling included.(b)(4), section 8.1.2."shark" resectoscope, pg 27.Warning! danger of injury! incorrect handling, e.G.Fall, shock, blows or similar mechanical loads can cause hair cracks and / or spalling of the ceramic coating in the distal area of the resectoscope sheath.Injuries of the patient, user or third parties are possible.Mind surface changes and ensure safe handling.Do not use damaged resectoscope sheaths, return damaged sheaths for repair.Check the ceramic insulation at the distal end of the resectoscope sheath for damage before every use.Replace damaged or brittle o-rings / caps (12.13).O-rings (1.3) (1.5) - "shark" resectoscope, rotatable [a ] [ b ] o-ring (7.5) - "shark" resectoscope with central stopcock [ c ] non-rotatable rw gmbh considers this mdr open.Rw gmbh will submit a follow up report when new information becomes available.
Event or Problem Description
Richard wolf medical instruments corp.(rwmic) reference (b)(4).It was reported to richard wolf medical instruments corp.(rwmic) that "tip broke off during a procedure.Delay time was 15 minutes." additional information reported by the initial reporter: 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? yes.Was the scheduled procedure completed? yes.Additional details about the adverse event; (b)(6) 2022.(1) what was the scheduled procedure being performed when the tip broke? transurethral incision of the prostate (tuip).(2) did the tip break inside or outside of the patient? yes.(3) what actions were being done during the delay? remove the tip of the sheath from the patient.(4) did the patient require any additional treatment during the delay or will require another procedure as the result of the delay? no.(5) what was the patient's outcome? no problem at the time of discharge.Rwmic mdr awareness date: (b)(6) 2022 also, the purpose of this submission is to provide the results of the device investigation.
Additional Manufacturer Narrative
Rwmic is submitting this report on behalf of the manufacturer richard wolf gmbh.Follow-up report #1 is to provide fda with new information received from the user facility.Rw gmbh considers this mdr closed.Should rwgmbh receive new information, a follow-up report will be submitted.
Event or Problem Description
Richard wolf medical instruments corp.(rwmic) reference complaint: (b)(4).The purpose of this report is to update mdr with new patient information, received from a representative of the user facility on 8/16/2022.

• Brand Name: SHARK
• Common Device Name: INTERNAL SHEATH RESECTOSCOPE 24FR
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; 75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• Manufacturer Contact: zsófia bartholome-nagy ; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• MDR Report Key: 15084780
• Report Number: 9611102-2022-00033
• Device Sequence Number: 4055583
• Product Code: FJL
• UDI-Device Identifier: 04055207019658
• UDI-Public: 04055207019658
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K062720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 8675324
• Device Catalogue Number: 8675324
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2022
• Supplement Date Received by Manufacturer: 08/16/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 67 KG
• Patient Race: White