MAUDE Adverse Event Report: RICHARD WOLF GMBH PANOVIEW PLUS HD; DISCOSCOPE 25° Ø 6.9MM SL 207MM

Model Number	892101254
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The discoscope 25° ø 6.9mm sl 207mm type 89210.1254 comes from production batch 1511904.The batch consists of 8 discoscopes.As of 21 december 2023, we have not received any further complaints about this batch.
Event or Problem Description
A distributor has informed richard wolf gmbh (rwgmbh) of an issue regarding a discoscope 25° ø 6.9mm sl 207mm, part id: 89210.1254, s/n # (b)(6).According to the received information, during an endoscopic spine surgery at chosun university hospital, they noticed that the scope lens was damaged.The surgery was performed by replacing the scope with another one.There was a reported 30 minutes delay but no special impact during the surgery.

• Brand Name: PANOVIEW PLUS HD
• Common Device Name: DISCOSCOPE 25° Ø 6.9MM SL 207MM
• 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: oliver ehrlich ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 18438478
• Report Number: 9611102-2023-00077
• Device Sequence Number: 7033806
• Product Code: HRX
• UDI-Device Identifier: 04055207035054
• UDI-Public: 04055207035054
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K000046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/03/2024

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: 892101254
• Device Catalogue Number: 89210.1254
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown