MAUDE Adverse Event Report: RICHARD WOLF GMBH PANOVIEW; TELESCOPE 12° Ø 2.7MM SL 310MM

Model Number	8974412
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During the inspection of the optics by the specialist department, it was determined in accordance with test instruction (b)(4) that the cladding tube was dented/crushed at distal.As a result, the glass in the optical system broke at this point, which impaired the image.The cladding tube was dented/crushed due to mechanical influences, e.G.Drop/impact damage.As a result of these influences, the glass in the system broke and the customer complained about a "dark line".This is a user defect.The present optic 8974.412 with serial number (b)(4) originates from production order (b)(4) (with an order size of 9 pieces) and was booked to the new goods warehouse on (b)(6) 2020.No discrepancies were found for this serial number during the review of the flow chart.The customer received the optics with delivery bill (b)(4) on 11.02.2020.Based on the evaluation of the available information, there is no direct patient risk because the product is no longer in use due to its image impairment.In general, the user is advised in the associated instructions for use (b)(4), under chapter 8, that a visual and functional check must be performed before and after each use and during reprocessing.Possible image impairments of the above type can be easily detected by hospital staff if these instructions are followed.The user's attention is also drawn to the limited stability of the product in chapter 7.Excessive application of force will damage the product and impair its function.In our risk analysis (b)(4), manufacturing-related, handling-related and design-related hazards with regard to a functional impairment as well as risks due to an unusable product with the corresponding extent of damage and the assumed probability of occurrence were considered.Probability of occurrence considered and assessed with an acceptable risk.Since no new risks have arisen from the investigation of the current complaint case, the risk assessment remains valid in view of the facts described.Richard wolf gmbh (rwgmbh) considers this matter closed.However, in the event rwgmbh receives any additional information a follow up report will be submitted to fda.Richard wolf medical instruments corporation (rwmic) submitting report on behalf of rwgmbh report on behalf of rwgmbh.
Event or Problem Description
It is reported by richard wolf gmbh, the customer told us that during the process the picture is darkened and no longer visible.Very poor quality of the image.There was an op extension of 10 minutes.The op could not be finished because the image was dark and there was no visibility.

• Brand Name: PANOVIEW
• Common Device Name: TELESCOPE 12° Ø 2.7MM SL 310MM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 11777112
• Report Number: 9611102-2021-00018
• Device Sequence Number: 19916241
• Product Code: FJL
• UDI-Device Identifier: 04055207023617
• UDI-Public: 04055207023617
• Combination Product (Y/N): Y
• Initial Reporter Country: LO
• PMA/510(K) Number: K062720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/03/2021

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: 8974412
• Device Catalogue Number: 8974412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2021
• 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