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

Model Number	8675324
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Richard wolf gmbh has been informed of an issue regarding an internal sheath resectoscope 24fr, part id: 8675324, batch# 1533973.According to the received information, during a holmium laser enucleation of the prostate (holep) procedure, the ceramic tip on the internal sheath resectoscope 24fr, part id: 8675324 with batch 1533973 became loose or broke off intraoperatively.However, this was only noticed after the procedure.The clinic will arrange for the patient to have x-rays taken again.
Additional Manufacturer Narrative
The following fields have new information: b4, g3, g6, h2, h3, h6 (type of investigation, investigation findings, investigation conclusions), h7, and h11.Richard wolf have since received information that the patient was x-rayed again, and no ceramic part was discovered.The attending physician therefore assumes that the broken piece did not fall into the patient but remained outside of the patient and was not discovered only after the operation.The inner sheath 8675324 was investigated in the responsible department at richard wolf gmbh.It was determined that the insulation insert had a punctual damage just before the left fracture edge, which indicates that the ceramic sleeve had been damaged previously.This probably led to cracking and subsequent breakage of the section.The probable root cause is user error.The internal sheath resectoscope 24fr, part id: 8675324, from batch 1533973, was produced on 22/dec/2022.There are no known complaints or repairs from this batch to date in the associated instructions for use ga-d366 / en / int / v1.0 / 2020-12, reference is made to visual and functional checks in chapter 9 "checks" and the limited stability of the products in chapter 10 "use".Furthermore, the user is advised to check the device prior and after each use.A better inspection before use would have revealed the pre-damage to the ceramic.The product then should not have been used on the patient.Accordingly, non-compliance with the ifu ga-d366 led to this incident.There is no general product problem.The subject issue of breakage and loss of parts is present in the risk management file d3 rev.04 "reusable shafts, tubes" and considered with the corresponding extent of damage and probability of occurrence.The overall probability of occurrence for this issue remains at previously defined levels and the overall risk of the device remains in the acceptable category.

• 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: anja ehrenfeuchter ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 20027561
• Report Number: 9611102-2024-00026
• Device Sequence Number: 12911711
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

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: 8675324
• Device Catalogue Number: 8675324
• Device Lot Number: 1533973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2022
• 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