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

Model Number	8675324
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Rwmic is submitting this report on behalf of the manufacturer richard wolf gmbh.Rw gmbh considers this mdr open.Rw gmbh will submit a follow up report after the device evaluation has been completed.
Event or Problem Description
Richard wolf gmbh complaint reference (b)(4).Planned surgery: video minimally invasive rtu bipolar procedure.During a video minimally invasive rtu bipolar procedure, the shark resectoscope sheath 8675324 broke the ceramic tip, which was lost in the patient's abdominal cavity.It was necessary to perform an open and more complex procedure to remove the loose part.Rwgmbh awareness date: 23-jun-2022.
Additional Manufacturer Narrative
The internal sheath resectoscope 24fr 8675324 was investigated in the responsible department.Upon investigation, it was found that the ceramic tip was broken off, but the broken part was also returned.There was a kink at the distal end and the surface is strongly scratched.A breakage of the ceramic tip is not to be expected when the device is used as intended, as only low forces are applied during the intended procedure.Such fractures are primarily due to mechanical influences, which can be caused by falling or impact damage.The kink can be caused by mechanical overload when excessive force on the device is used.The internal sheath resectoscope 24fr 8675324, batch # 1453121 was manufactured on 18/aug/2020.The batch consisted of 20 pieces.No issues were identified during production, no further complaints were received from the reported batch.The ifu ga-d366-us / en / 2017-02 v4.0 / eco 2016-0202 contains several instructions of visual and functional checks prior and after each use in section 8 checks.Furthermore, the user is advised about the limited strength of the device in section 7 operating instruction.The subject issue of breakage of the tip due to mechanical influences as well as the subject issue of kink at the distal end were present in the risk management file d3 - reusable shafts, tubes, rev.04.The overall probability of occurrence for this issue remains at previously defined levels and 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 2; d-75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 2; 75438 knittlingen, germany ; GM
• Manufacturer Contact: oliver ehrlich ; pforzheimer strasse 2; 75438 knittlingen, germany ; GM
• MDR Report Key: 14932666
• Report Number: 9611102-2022-00029
• Device Sequence Number: 20208000
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2023

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: Other
• Device Model Number: 8675324
• Device Catalogue Number: 8675324
• Device Lot Number: 1453121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2022
• Supplement Date Received by Manufacturer: 10/28/2022
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2020
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown