MAUDE Adverse Event Report: RICHARD WOLF GMBH PANOVIEW; MORCESCOPE 0° 24FR WL 199MM

Model Number	8970407
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Richard wolf gmbh (rwgmbh) has received a "user-notification" report no.(b)(4) from an importer, amt surgical in canada.The reported issue is regarding a morcescope 0° 24fr wl 199mm, part id: 8970407, sn# (b)(6).According to the received information, the morcelator scope was blurry, and the surgeon could not visualize field in order to continue procedure.Also, could not turn over other scope in an appropriate period.Later, rwgmbh received information that the patient's surgical procedure was cancelled while not completed, and had to be rescheduled to complete the operation.
Additional Manufacturer Narrative
The cause analysis cannot be carried out, as the instrument has not yet been sent in.However, in general, the ga-d336 "tests" instructions for use contain warning and caution.In addition, careful and gentle handling as well as the user's behavior in the event of non-observance of the above-mentioned control points are pointed out.Possible hazards were assessed as acceptable in the a1-2 risk assessment, taking into account the respective extent of damage and the probability of occurrence.

• Brand Name: PANOVIEW
• Common Device Name: MORCESCOPE 0° 24FR WL 199MM
• 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: heiko seider-biedermann ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 20080270
• Report Number: 9611102-2024-00027
• Device Sequence Number: 18037370
• Product Code: FJL
• UDI-Device Identifier: 04055207055113
• UDI-Public: 04055207055113
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K041610
• 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,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/27/2024

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: 8970407
• Device Catalogue Number: 8970407
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2022
• 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