MAUDE Adverse Event Report: RICHARD WOLF GMBH PANOVIEW; NEPHROSCOPE 12° 20.8FR WL 224MM

Model Number	8964401
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility has informed (b)(6) of an issue regarding a nephroscope 12° 20.8fr wl 224mm, part id: 8964.401, sn (b)(6).According to the received information, there was insufficient light transmission during the operation (percutaneous nephrolitholapaxy).The scheduled procedure was completed.However, the operation time was extended by 30 minutes to change to a replacement device.The device had to be replaced intraoperatively.There is no report of injury to the patient or other personnel.
Additional Manufacturer Narrative
The reported device was evaluated by (b)(6) responsible department.The examination has revealed that the defect "light transmission too low" described by the customer could not be confirmed, as the light intensity of 25 lumens measured is acceptable for used instruments.However, moisture was found in the system, which can impair the quality of vision.The nephroscope 12° 20.8fr wl 224mm, part id: 8964.401, sn (b)(6), was manufactured on 03/may/2023 in a production batch of 10 units.The affected serial number was downgraded with an optical defect error code 12 (damage in the optical system) and 180 (processing).Both defects had no functional impairment.The instrument was delivered to the customer as an exchange item on 11/jul/2023.There have been no further complaints about this serial number since delivery.The evaluation of the complaints database from 01/jan/2021 to 25/jan/2024 has shown that there were a total of (b)(4) complaints about this type in the period concerned, but no comparable cases.According to current information and assessments, a general product problem can be ruled out.The fault is considered to be a sporadic failure.At the same time, the fault that occurred here could easily have been detected by the user if the instructions for use had been followed correctly and the instrument could therefore have been replaced in good time.In general the instructions for use ga-d318 / en / index: 2019- 03 v7.0 / pk18- 9399 contains information on applicable checks: visual and functional checks in chapters 7.1 and 7.2.In addition, chapter 7.2.1: panoview plus op endoscope refers specially to check image quality for any deposits on the glass surfaces that may result in a spotted or blurred field of vision and can considerably impair light transmission, as well as, check the light output in conjunction with the system components.Possible hazards in the risk assessment a1: reusable rigid optics, document no."(b)(4).Rigid optics vo1' with the corresponding extent of damage and probability of occurrence and were assessed as acceptable.

• Brand Name: PANOVIEW
• Common Device Name: NEPHROSCOPE 12° 20.8FR 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: 18789966
• Report Number: 9611102-2024-00006
• Device Sequence Number: 8296463
• Product Code: FGA
• UDI-Device Identifier: 04055207023266
• UDI-Public: 04055207023266
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Type of Report: Initial
• Report Date (Section B): 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8964401
• Device Catalogue Number: 8964.401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown