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

Model Number	8964.401
Medical Device Problem Code	Optical Distortion (3000)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing.The device has currently not been returned by the user to richard wolf gmbh.A follow-up report will be submitted as soon as the investigation is completed.Rw mic is filing this report on behalf of rw gmbh.
Event or Problem Description
It was reported to richard wolf that at 15:00 p.M.On (b)(6) 2020, the patient underwent percutaneous nephrolithotomy and ureteroscopic bilateral ureteral stent placement under general anesthesia.After the operation of bilateral ureteral stent placement under ureteroscope, the doctor found that the nephroscope could not complete the white balance, the nephroscope was blurred and could not be used normally when preparing the percutaneous nephroscope instruments at 16:20.The nurse immediately informed the medical device department for maintenance and emergency deployment.The device department immediately deployed a nephroscope at 17:45, the operation continued, and the patient returned to the ward at about 18:20.This led to a prolonged operation time and the risk of intraoperative hemorrhage.The operation was performed by emergency deployment of nephroscope outside the hospital.This increased the risk of intraoperative infection.

• Brand Name: PANOVIEW
• Common Device Name: NEPHROSCOPE 12° 20.8FR WL 224MM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 10549723
• Report Number: 9611102-2020-00020
• Device Sequence Number: 19669314
• Product Code: FGA
• UDI-Device Identifier: 04055207023266
• UDI-Public: 04055207023266
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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,health professional
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 09/16/2020

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: 8964.401
• Device Catalogue Number: 8964.401
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other