MAUDE Adverse Event Report: RICHARD WOLF GMBH PANOVIEW PLUS HD; DISCOSCOPE 25° Ø 5.9MM SL 122MM

Model Number	892107253
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Richard wolf medical instruments corporation (rwmic) received a medwatch report, mw5118856, regarding an issue with a discoscope 25° ø 5.9mm sl 122mm, part id: 892107253, serial # (b)(6).The medwatch report, mw5118856, states that the "scope was blurry during a case, causing a delay in case and increased anesthesia time.Sterilization issues ruled out (no leaks).Customer stated the scope had recenly been repaired in (b)(6) 2023 for same issue." according to the initial reporter, the reported issue caused a 20 minute delay in the procedure while the back-up device was retrieved to complete the scheduled procedure.The reporter stated the delay in the procedure resulted in the patient being at potential risk due to the increased anesthesia time.There was no additional treatment or procedure needed.There is no report of injury to the patient or other personnel as a result of the reported issue.
Additional Manufacturer Narrative
Rwmic has no record of (b)(6) repair found.

• Brand Name: PANOVIEW PLUS HD
• Common Device Name: DISCOSCOPE 25° Ø 5.9MM SL 122MM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• MDR Report Key: 17397565
• Report Number: 1418479-2023-00018
• Device Sequence Number: 18072810
• Product Code: HRX
• UDI-Device Identifier: 04055207035092
• UDI-Public: 04055207035092
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/26/2023
• Report Date (Section F): 07/26/2023

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: 892107253
• Device Catalogue Number: 892107253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2023
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/12/2023
• Device Age: 5 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 07/26/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2023
• 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
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Date Report Sent to FDA: 07/26/2023