MAUDE Adverse Event Report: RICHARD WOLF GMBH SHARK; OUTER SHEATH RESECTOSCOPE 26FR

Model Number	8675426
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Unspecified Kidney or Urinary Problem (4503)
Date of Event	06/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Richard wolf gmbh (rw) performed an evaluation of the reported device, outer sheath resectoscope 26fr, part id: 8675426, lot# 1381365, together with the complete device system used at time of surgery.The examination showed that all the devices used in the system exhibited a severe kink (bent) at the same point.Apparently, this was due to excessive mechanical overload when devices were assembled.In the instructions for use (ga-d374 / en / us / v1.0 / 2024-03 /), the user is made aware of the limited stability of the products and is warned against applying strong force.As it turned out, medworx gmbh has repaired the inner shaft, 8675324, and the working element, 8680205, of the device.Medworx gmbh is not authorized by rw to carry out repairs or service on rw products.This is an unauthorized and incomprehensible repair.For this reason, these devices no longer correspond to the design and no longer comply with richard wolf gmbh specifications.Therefore to be treated as third-party device.Due to this reason, rw cannot make any further evaluations or other statements.According to the investigation results, rw cannot identify any product risk in this case, as devices of the system used have been modified by unauthorized repairs.The device no longer complies with richard wolf specifications and is therefore treated as a third-party device within the scope of the (b)(4) mdr (b)(4).
Event or Problem Description
Richard wolf gmbh has been informed of an issue regarding an outer sheath resectoscope 26fr, part id: 8675426, lot# 1381365.According to the received information, "when performing a transurethral resection (tur) of the bladder, the shaft of the device was bent.This resulted in a lesion of the urethra.As a result, the operating time was extended by 2 hours and additional unscheduled medical measures had to be taken." the scheduled surgical procedure was completed and no additional surgery was performed.

• Brand Name: SHARK
• Common Device Name: OUTER SHEATH RESECTOSCOPE 26FR
• 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: anja ehrenfeuchter ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 19666367
• Report Number: 9611102-2024-00023
• Device Sequence Number: 6822565
• Product Code: FJL
• UDI-Device Identifier: 04055207019672
• UDI-Public: 04055207019672
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/03/2024

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: 8675426
• Device Catalogue Number: 8675426
• Device Lot Number: 1381365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 8654522: OPTICS BLUE 30° 0 4MM NL 299MM; 8675324: INNER SHAFT FOR RESECTOSCOPE 24CH; 8680205: WORKING ELEMENT ACTIVE BIPO 0/12/30°
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 94 KG