MAUDE Adverse Event Report: RICHARD WOLF GMBH PANOVIEW; TELESCOPE 30° Ø 2.7MM SL 310MM

Model Number	8974402
Medical Device Problem Codes	Moisture or Humidity Problem (2986); Optical Obstruction (3002)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility representative reported regarding telescope 30° ø 2.7mm sl 310mm, part # 8974402, sn.(b)(4)."the scope was unclear during a procedure and could not see, so the dr.Stopped the procedure".Additional information was received from the user facility representative on january 27, 2023.According to the received information, the scheduled procedure was not completed, the user stopped the procedure due to image loss.A follow-up procedure is necessary to complete the planned treatment.
Additional Manufacturer Narrative
During the inspection of the telescope 30° ø 2.7mm sl 310mm, part # 8974402, sn.(b)(4) by richard wolf medical instruments corporation in accordance with the test instructions, it was confirmed that the scope received had an unclear image.Additionally the scope housing was bent and with broken lenses.Also, there was moisture in the optic system.According to the findings, it is a potential handling problem at the user side.The telescope 30° ø 2.7mm sl 310mm, part # 8974402, was manufactured on 01/feb/2019.An analysis of the production records shows no abnormalities found during manufacturing.The device was returned for repair on 05/dec/2022 and found that fibers are broken and scope housing leaks.Thus, creating moisture inside the optics.The instructions for use, ga-s001 / en-us / 2017-03 v3.0 / eco 2016-0136 contains several descriptions of visual and functional checks which serve to detect faults prior to use on patient in sections 8: visual and function check, as well as caution note about the image quality in section 7.2.3 "check the image quality of the endoscope before use".The subject issue of bad image quality 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
• Common Device Name: TELESCOPE 30° Ø 2.7MM SL 310MM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• MDR Report Key: 16409159
• Report Number: 1418479-2023-00002
• Device Sequence Number: 6142110
• Product Code: FJL
• UDI-Device Identifier: 04055207023600
• UDI-Public: 04055207023600
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/21/2023
• Report Date (Section F): 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8974402
• Device Catalogue Number: 8974.402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2023
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/27/2023
• Device Age: 4 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/21/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/21/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/21/2023