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

Model Number 892107253

Device Problem Poor Quality Image (1408)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/06/2023

Event Type  Injury  

Event 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.

Manufacturer Narrative

Rwmic has no record of (b)(6) repair found.

• Brand Name: PANOVIEW PLUS HD
• Type of Device: 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
• MDR Text Key: 319834301
• Report Number: 1418479-2023-00018
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 04055207035092
• UDI-Public: 04055207035092
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 07/26/2023
• Distributor Facility Aware Date: 07/12/2023
• Device Age: 5 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 07/26/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 76 KG