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

Model Number	892101254
Medical Device Problem Codes	Moisture or Humidity Problem (2986); Optical Obstruction (3002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user reported the following: due no vision of the optic during the endoscopic spine surgery, the surgeon took the decision make open spine surgery.Externally the optic looks like new, but completely dark vision, the client demands an explanation, repair or replacement of the lens."without vision of the optic 89210.1254, the endoscopic spine surgery failed.".
Additional Manufacturer Narrative
During the inspection of the diskoskop 25° ø 6,9mm sl 207mm, part no.89211254, serial #(b)(4) by richard wolf gmbh, it was determined in accordance with test instructions that there was moisture in the optical system, which caused cloudy vision.After a period of use of approx.18 months and since neither the sealing ring nor the sealing surfaces show any abnormalities/damage, it is assumed that the seal between the cladding tube and the funnel holder has failed sporadically.The diskoskop was produced on 10/jun/2021, the production order consisted of 8 discoscopes.The subject discoscope was delivered to the customer on 16/jun/2021.The ifu ga-b 223 / usa / 2012-10 v5.0 / eco 2012-0519 contains several descriptions of visual and functional checks which serve to detect faults prior to use on patient in section 6 use and section 7 check.In addition the ifu states that the product must be checked for damage, loose parts and completeness immediately before and after use.The subject issue of cloudy / obscured optics is present in the risk management file a1 - reusable rigid telescopes with and without working channel, rev.05.The overall probability of occurrence for this issue remains at previously defined levels and overall risk of the device remains in the acceptable category.

• 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; d-75438, knittlingen, germany ; GM
• Manufacturer Contact: heiko seider-biedermann ; pforzheimer strasse 32; d-75438, knittlingen, germany ; GM
• MDR Report Key: 16387151
• Report Number: 9611102-2023-00007
• Device Sequence Number: 5515096
• Product Code: HRX
• UDI-Device Identifier: 04055207035054
• UDI-Public: 04055207035054
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: D274504
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/16/2023

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?: No
• Operator of Device: Other
• Device Model Number: 892101254
• Device Catalogue Number: 89210.1254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2021
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown