MAUDE Adverse Event Report: RICHARD WOLF GMBH PANOVIEW PLUS; NEPHROSCOPE 20° 24FR WL 224MM

Model Number	8965401
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility has informed us of an issue regarding a nephroscope 20° 24fr wl 224mm, part id: 8965401, serial number # (b)(6).According to the received information, the nephroscope failed during the case: "when using the nephroscope, the image suddenly disappeared and then came back, and this happened several times.Surgery delay 1 hour." according to the user facility, there was no danger to the patient, user or third parties.The operation has been fully completed.
Additional Manufacturer Narrative
The nephroscope 20° 24fr wl 224mm part id: 8965401, serial number # (b)(6) was added to the new goods inventory on 03/mar/2023.The production order consisted of 10 pieces.No issue was identified during production and no further complaints were received from the reported serial number.The nephroscope 20° 24fr wl 224mm type 8965401, serial number # (b)(6) was investigated in the responsible department.It was determined that: - the lens is leaking at the distal cementing to the cladding tube (sporadic failure of the cementing).Due to this leakage, moisture could enter the optical system at the distal area of the cladding tube during steam sterilization.As a result, all of the lenses are discolored/dirty and the image is severely degraded.The cladding tube is slightly bent due to mechanical overload.The associated ifu ga-d 320 / usa / 2014-01 v1.0 / eco 2013-0474 contains several safety instructions and notes regarding image impairments.In general, the user is informed in chapters 6.2.3 and 7 of the associated instructions for use, that a visual and functional check must be carried out before and after each use.I.A.The products must be checked in terms of image quality before and after each application and during reprocessing.Possible image impairments of the above type can be easily recognized by the hospital staff if these instructions are followed.Chapter 6 also refers to the limited stability of the products.Excessive use of force leads to damage to the product, impairs its function and thus endangers the patient.In the period under review from 01/jan/2020 and 25/jan/2023, there have been 5 comparable cases of sporadic failure of the cementing on the lens, which were, however, sorted out by the customer before use.In our risk analysis a1 rev.05, manufacturing-related, handling-related and design-related hazards with regard to a 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.The overall probability of occurrence for this issue is consistent at previously defined levels and overall risk of the device remains in the acceptable category.

• Brand Name: PANOVIEW PLUS
• Common Device Name: NEPHROSCOPE 20° 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: vatceslav gerdt ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 17616115
• Report Number: 9611102-2023-00052
• Device Sequence Number: 2599335
• Product Code: FGA
• UDI-Device Identifier: 04055207023310
• UDI-Public: 04055207023310
• Combination Product (Y/N): N
• Initial Reporter Country: TS
• PMA/510(K) Number: K994223
• 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
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 08/24/2023

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: 8965401
• Device Catalogue Number: 8965.401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2023
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown