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	Serious Injury
Additional Manufacturer Narrative
Device investigation results: rwmic investigating 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 for device labeling included.Ifu ga-d336-us, 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.Rwmic considers this mdr open.A follow-up report will be submitted when new information becomes available.
Event or Problem Description
Rwmic reference complaint no.(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.What was the scheduled procedure being performed when the tip broke? transurethral incision of the prostate (tuip).Did the tip break inside or outside of the patient? yes.What actions were being done during the delay? remove the tip of the sheath from the patient.Did the patient require any additional treatment during the delay or will require another procedure as the result of the delay? no.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.See manufacturers narrative.
Additional Manufacturer Narrative
Follow-up report #1 is to provide fda with new information received from the user facility.Rwmic considers this mdr closed.Should rwmic receive new information, a follow-up report will be submitted.
Event or Problem Description
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 (b)(6) 2022.

• Brand Name: SHARK
• Common Device Name: INTERNAL SHEATH RESECTOSCOPE 24FR
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 2; d-75438 knittlingen, germany ; GM
• MDR Report Key: 15084792
• Report Number: 1418479-2022-00019
• Device Sequence Number: 3879308
• Product Code: FJL
• UDI-Device Identifier: 04055207019658
• UDI-Public: 04055207019658
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2022
• Report Date (Section F): 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/23/2022
• Device Age: 3 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/17/2022
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 08/17/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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
• Date Report Sent to FDA: 08/17/2022