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	09/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility has informed richard wolf gmbh of an issue regarding a sheath resectoscope 24fr, part id: 8676424, batch# 1433702.The user reported that at the end of the operation, an immediate follow-up check of the equipment revealed that the tip of the resectoscope shaft was missing.After a brief x-ray check, the tip was found lying in the bladder and the broken part was removed using a cystoscope and grasping forceps.There were no further complications for the patient.Additional unscheduled measures had to be taken, namely x-ray control and removal of the resectoscope tip.These measures led to a delay in surgery of 25 minutes.
Additional Manufacturer Narrative
The sheath resectoscope 24fr, part id: 8676424 from batch 1433702, consisting of 3 pieces, was produced on 31/oct/2019, the production data show no abnormalities.An evaluation of the complaints has shown that there has already been one complaint with the same defect pattern for the same batch on 08/dec/2021.An evaluation of comparable errors has shown that there have been a total of 2 complaints in the past 3 years.A systematic error can be ruled out, as in the period from 01/jan/2019 to today a total of 243 sockets have been sold with only 2 complaints.

• 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: 18147785
• Report Number: 9611102-2023-00068
• Device Sequence Number: 7512296
• Product Code: FJL
• UDI-Device Identifier: 04055207019740
• UDI-Public: 04055207019740
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/16/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 8676424
• Device Catalogue Number: 8676424
• Device Lot Number: 1433702
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2019
• 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: Other
• Patient Sex: Unknown