MAUDE Adverse Event Report: RICHARD WOLF GMBH PANOVIEW; MORCESCOPE 0° 24FR WL 224MM

Model Number	8970405
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Richard wolf gmbh has been informed of an issue regarding a morcescope 0° 24fr wl 224mm, part id: 8970405, sn# (b)(6).According to the received information, at the beginning of the prostate enucleation via morcellation, the attending physician had prepared the instrument to begin the procedure.Upon reaching the bladder, his vision was excellent, but after a short time, visibility deteriorated as the optics became cloudy.The instrument was checked again why the lens was cloudy.However, optics remain foggy.Under these conditions, the doctor completed the procedure with difficulty.In addition, this led to a prolonged surgery and extended anesthesia time of one (1) hour.
Additional Manufacturer Narrative
An evaluation of the morcescope 0° 24fr wl 224mm, part id: 8970405, sn# (b)(6), was performed by the specialist department at richard wolf gmbh.During the inspection of the device, it was found that there is moisture in the optical system, which is clouding the image.The leak test revealed a slight leak in the cementing between the lens and the system tube, allowing moisture to penetrate and contaminate the optical system.There are no signs of improper handling in the area of the distal end surface.Customer fault is not recognizable in this context.The optics show normal signs of use in the form of superficial scratches and a slightly bent envelope tube, which have not caused any consequential damage.The existing traces of use proved that the morcescope has been used without any problems during the entire time with the user facility.After a delivery period of approx.9 months, the leakage that occurred on the lens has been determined as a sporadic failure.In general, the user is advised in the ga-d336 / en / 2018-12 v9.0 / pk19-9377 instructions for use in chapter 10 that a visual and functional check must be carried out before and after each use, including with regard to image and light quality.Possible image impairments of the type described above can be easily detected if these instructions are followed.In our risk analysis a1 "reusable rigid optics", rev.01, manufacturing-related, handling-related and design-related hazards with regard to functional impairment as well as risks due to an unusable product with the corresponding extent of damage and the assumed probability of occurrence were considered and assessed with an acceptable risk.As no new risks have arisen from the investigation of the current complaint, the risk assessment remains valid in view of the circumstances described.

• Brand Name: PANOVIEW
• Common Device Name: MORCESCOPE 0° 24FR WL 224MM
• 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: 19344874
• Report Number: 9611102-2024-00019
• Device Sequence Number: 21017727
• Product Code: FJL
• UDI-Device Identifier: 04055207055106
• UDI-Public: 04055207055106
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/17/2024

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: Other
• Device Model Number: 8970405
• Device Catalogue Number: 8970405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2023
• 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