MAUDE Adverse Event Report: RICHARD WOLF GMBH SHARK; INTERNAL SHEATH RESECTOSCOPE 22FR

Model Number	8675322
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility has informed richard wolf gmbh of an issue regarding an internal sheath resectoscope 22fr, part id: 8675322, batch # 1457849.According to the received information, the bakelite (tip) fell into the patient during surgery.It was picked up by the surgeon.The incident occurred in the end of surgery.There was a reported delay in the surgery.However, no consequences for the patient.
Additional Manufacturer Narrative
The internal sheath resectoscope 22fr 8675322, batch # 1457849 was manufactured on 02/sep/2020.The batch consisted of 39 pieces.No issue was identified during production and no further complaints were received from the reported batch.Further investigation is ongoing.
Additional Manufacturer Narrative
New information: h6 (type of investigation, investigation findings, investigation conclusions).The internal sheath resectoscope 22fr, part id: 8675322, batch#: 1457849 was investigated at rwgmbh.The investigation revealed that the insulation insert has a typical broken edge caused by mechanical overload.The distal undamaged edges are regular and completely intact.Mechanical pre-damage in connection with the formation of the smallest stress cracks within the ceramic can lead to a fracture of the ceramic and thus to a possible loss of parts even with a low mechanical load on the product during use.A breakage of the insulation tip is not to be expected under normal application conditions and when used as intended, as only low forces act during endoscopic applications.Experience shows that such breakages are primarily due to mechanical damage/pre-damage and are possibly triggered by a point load such as by impact, shock, falling down or similar which may occur during preparation of instruments for surgery, during transport to and from the or, during cleaning of instruments, during sterilization, etc.The ifu ga-d366-us / en / 2017-02 v4.0 / eco 2016-0202 contains safety instructions regarding checking the device prior and after each use, especially the ceramic insulation at the distal end in section 8 checks.Furthermore, the user is advised to avoid using excessive force on the device in section 7 operating instruction.The subject issue of broken ceramic tip is present in the risk management file d3 - reusable sheaths, tubes, rev.04.The overall probability of occurrence for this issue is consistent at previously defined levels and overall risk of the device remains in the acceptable category.

• Brand Name: SHARK
• Common Device Name: INTERNAL SHEATH RESECTOSCOPE 22FR
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• Manufacturer Contact: heiko seider-biedermann ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 16976952
• Report Number: 9611102-2023-00027
• Device Sequence Number: 19412716
• Product Code: FJL
• UDI-Device Identifier: 04055207019641
• UDI-Public: 04055207019641
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2023

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
• Operator of Device: Other
• Device Model Number: 8675322
• Device Catalogue Number: 8675322
• Device Lot Number: 1457849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2023
• Supplement Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2020
• 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: Other
• Patient Sex: Unknown