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

Model Number	8675324
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	06/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility has informed richard wolf gmbh an issue regarding a internal sheath resectoscope 24fr, part id: 8675324, serial # (b)(6).According to the received information, "during surgery, sudden shearing off of an approx.1 cm long cylindrical foreign body corresponding to the inside of the resectoscope shaft.Due to incorrect use of the snare resection, this defect was only detected optically afterwards.The foreign body was then removed endoscopically with grasping forceps.By changing the surgical technique, the patient could be treated with a prolonged surgical time as initially.".
Additional Manufacturer Narrative
Internal sheath resectoscope 24fr 8675324, batch # 1452559 was manufactured on 07/22/2020.The batch consisted of (b)(4) pieces.No issue was identified during production and no further complaints were received from the reported batch.
Additional Manufacturer Narrative
The user reported that during surgery, an approximately 1 cm long cylindrical part corresponding to the inside of the resectoscope shaft was suddenly sheared off.Due to improper use of the resection snare, this defect was visually detected only after the fact.The foreign body was then removed endoscopically with grasping forceps.With a change in surgical technique (to resectoscopy), the patient could be treated as originally with extended surgical time.During the inspection, it was noted that the insulating insert had a clearly visible notch on the distal outer edge, indicating prior user damage to the ceramic sleeve that caused the loss during the surgery.The internal shaft for resectoscope 24fr, part id: 8675324, from batch 1452559, consisting of (b)(4) pieces, was produced on (b)(6) 2020, the production data shows no abnormalities.One inner shaft from this batch was sold to srh kliniken landkreis sigmaringen on (b)(6) 2020.In the associated instructions for use ga-d366 / en / int / v1.0 / 2020-12, which was valid at the time of delivery, reference is made in chapter 9 "tests" to visual and functional tests and in chapter 10 "use" to the limited stability of the products.Due to the visible notch on the distal outer edge, the device should have been sorted out and should not been used.Possible hazards were classified as acceptable in the risk assessment d3 rev.04 "reusable manholes, pipes" and considered with the corresponding extent of damage and probability of occurrence.

• Brand Name: SHARK
• Common Device Name: INTERNAL 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: 17240803
• Report Number: 9611102-2023-00039
• Device Sequence Number: 4834405
• Product Code: FJL
• UDI-Device Identifier: 04055207019658
• UDI-Public: 04055207019658
• 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,Followup
• Report Date (Section B): 08/02/2023

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: Health Professional
• Device Model Number: 8675324
• Device Catalogue Number: 8675324
• Device Lot Number: 1452559
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2023
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2020
• 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