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

Model Number	8676424
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility has informed richard medical instruments corp.(rwmic) of an issue regarding a sheath resectoscope 24fr, part id: 8676424, lot # 1497661.According to the received information," beak of the shaft end is broken.When the scope and sheath were in the bladder, a black piece of material was seen and removed.Once removed we realized it was part of the sheath.We looked at the sheath and saw that it was broken." there is no report of injuiy to the patient or other personnel as a result of the reported issue.However, the reported issue caused a short delay during the beginning of a transurethral resection bladder tumor procedure while the back-up device was retrieved to complete the scheduled procedure.There was no additional treatment or procedure needed.The complainant confirmed there was no risk to the patient as the tip was successfully retrieved.
Additional Manufacturer Narrative
Patient information: the user facility was contacted several times in an effort to collect patient information.Rwmic has not received any response.Device evaluation: the sheath resectoscope 24fr, part id: 8676424, batch # 1497661 was investigated at richard wolf medical instruments corporation (rwmic).The instrument was inspected according to test procedure tp-341 rev 00.During evaluation, the responsible department found the distal ceramic insert was chipped.The evaluation indicates that impacts or even similar mechanical stress against solid surfaces can lead to hairline cracking and/or ceramic chipping in the distal area of the resectoscope shaft.Minute cracks developed during stresses are sufficient to damage the ceramic insert.In this case, improper handling from use or reprocessing is most likely the probable root cause.The instrument 8676424, with the batch number 1497661 was produced on 11/nov/2021.The batch size was 5 pieces.Records analysis of previous complaints showed that there were 4 cases in the last 3 years with similar failure.No other sheath resectoscope from this batch number, has been claimed so far.In general, the user is advised in the associated ga-d366 / en / int / v1.0 / 2020-12 / instructions for use under chapter 9 that a visual check for damages, loose or missing parts must be performed before and after each use.In section 9.1.2, the user is advised to pay attention to surface changes and safe handling and not to use damaged resectoscope sheath and to return it for repair.Check the ceramic insulation at the distal end of the resectoscope sheath for damage before each use.Potential hazards have been considered in the risk analysis d3 "reusable sheaths, tube" rev.04 risk assessment (reusable sheaths, tubes) with the corresponding extent of damage and probability of occurrence.In our risk analysis d3 "reusable sheaths, tube", under the point 9 5.8 hazards posed by energy, handling-related hazards with regard to a functional impairment as well as risks due to an unusable product with the corresponding extent of damage and the assumed probability of occurrence were considered and assessed with an acceptable risk.

• Brand Name: SHARK
• Common Device Name: SHEATH RESECTOSCOPE 24FR
• 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: valentin felsing ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 18260528
• Report Number: 9611102-2023-00072
• Device Sequence Number: 7690858
• Product Code: FJL
• UDI-Device Identifier: 04055207019740
• UDI-Public: 04055207019740
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8676424
• Device Catalogue Number: 8676424
• Device Lot Number: 1497661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 01/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2021
• 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
• Patient Sex: Unknown