MAUDE Adverse Event Report: RICHARD WOLF GMBH PANOVIEW PLUS DISKOSKOP; DISCOSCOPE 25° Ø 6.9MM SL 165MM

Model Number	89210.3254
Medical Device Problem Code	Optical Obstruction (3002)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Rwmic reference complaint no.(b)(4).It was reported to richard wolf medical instruments corp.(rwmic) that "this t&e (trial & evaluation) scope was in use at lone peak surgery center located in draper, ut.The scope when dark during a two-level interlaminar procedure.One level was completed and one level was not completed." additional information reported by the initial reporter: will the device be returned? yes.Was the device being used on a patient when the reporting issue occurred? yes.Was there any injury or illness to the patient due to the reported issue? no.Was there any injury or illness to any other personnel due to the reported issue? no.Did the issue cause a delay in the procedure being performed? yes.Did the delay put the patient at risk? yes.Was there a similar back-up device available for use? no.Was the scheduled procedure completed? no.Additional details about the adverse event; (b)(6) 2022.There is no report of injury to the patient or any other personnel as a result of the reported issue.There was a report of a delay in the procedure that put the patient at risk.There was no back-up device available and the scheduled procedure was aborted resulting in an incomplete surgery.The patient's outcome was poor as the immediate post-op was suboptimal and not an expected outcome.The completion of the procedure is pending a repeat mri.Rwmic mdr awareness date: (b)(6) 2022.
Additional Manufacturer Narrative
Rwmic considers this mdr open.Rwmic will submit a follow-up report after the device evaluation has been completed and/or new information becomes available.
Additional Manufacturer Narrative
Follow-up report #1 is to provide fda with the results of the device investigation as well as due diligence for patient information.Results of due diligence for patient information: the user facility was contacted several times in an effort to collect patient information.As of (b)(6) 2022, rwmic has not received any response.Dates of user facility contact: 1st attempt: (b)(6) 2022 via email: no response.2nd attempt (b)(6) 2022 via email: no response.3rd attempt: (b)(6) 2022 via email: no response.Results of device investigation: (rwgmbh investigation report device evaluation, form 5020 (13), dated: (b)(6) 2022).Reported condition findings: according to the findings, the sheath tube is bent and dented in some spots.The optical fiber is chemically thermally damaged.Due to fall damage, the eyepiece funnel is flaked off.The image sharpness is misaligned and the optical system is heavily soiled.Additional findings: the device has an old design.There is no spare part for the current sheath tube.Probable root cause rationale: the manufacture date of the device is (b)(6) 2014.The device was delivered to the user from rwmic on (b)(6) 2022 after the last repair.According to the findings, the probable root cause is user error/ reprocessing error.The user is advised in the relevant ifu ga-b223 i usa/ 2012--10 v5.O / eco 2012-0519 in section 7 checks about the visual and functional check of the device before and after each use.Furthermore, there are safety notices in section 6, use about the limited strength of the device as well as in section 6.2.3 image quality, about a potential risk for the patient if the image is blurred.Recommended product disposition: the device will be scrap.The customer will be offered a current model of the device as replacement.
Event or Problem Description
Rwmic reference complaint no.(b)(4).The purpose of this submission is to report the results of the device evaluation and due diligence for patient information.See h10.Rwmic final mdr (device investigation) awareness date: (b)(6) 2022.

• Brand Name: PANOVIEW PLUS DISKOSKOP
• Common Device Name: DISCOSCOPE 25° Ø 6.9MM SL 165MM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 2; d-75438 knittlingen, germany ; GM
• MDR Report Key: 15018040
• Report Number: 1418479-2022-00018
• Device Sequence Number: 14052334
• Product Code: HRX
• UDI-Device Identifier: 04055207035078
• UDI-Public: 04055207035078
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2022
• Report Date (Section F): 12/15/2022

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
• Device Model Number: 89210.3254
• Device Catalogue Number: 89210.3254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/21/2022
• Device Age: 8 YR
• Event Location: Other
• Date Report to Manufacturer: 12/15/2022
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 12/15/2022
• 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: Required Intervention; Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/15/2022