MAUDE Adverse Event Report: RICHARD WOLF GMBH PANOVIEW; TELESCOPE 12° Ø 4MM WL 297MM RIGID

Model Number	8654431
Medical Device Problem Codes	Poor Quality Image (1408); Optical Distortion (3000)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Rwmic is submitting this report on behalf of richard wolf (b)(4).Rw (b)(4) is in the process of investigating this complaint.A follow up report will be submitted with the investigation results.
Event or Problem Description
The user describes the incident as follows: "neu optic of our operative hysteroscope (resectoscope) is defective.Unfortunately, i had to realize this during the treatment that the image is very blurry, i can only recognize the objects hazy as it was through a frosted glaze.I had to cancel the surgery because there was no sharp image possible." richard wolf (b)(4) complaint reference (b)(4).
Additional Manufacturer Narrative
Follow-up report #1 is to provide fda with results of the device evaluation plus new information and changed information.The following fields have new or changed information: b5, d8, g2, g3, g6, h3, h5, h7, h10o.The results of the device evaluation: the telescope 12° ø 4mm wl 297mm was checked at rw gmbh in (b)(6).Due to leakage, moisture has penetrated the optical system.This has led to clouding the image.Attempts by the user to improve the image quality by cleaning the telescope were unsuccessful.Then the user decided to cancel the surgery and perform another surgery later.Causes and reasons, why no replacement of the telescope was available, are unknown.The user is informed in the ifu ga-s001 / en-us / 2017-03 v3.0 / (b)(4) about the visual and functional checks before and after each use: section 7 application caution! the products have only limited strength! excessive force will cause damage, impair the function and therefore endanger the patient.Immediately before and after each use, check the products for damage, loose parts and completeness.Make sure that no missing parts remain in the patient.Do not use the products if they are damaged or incomplete or have loose parts.Section 7.2.3 image quality caution! increased risk potential if the image is blurred! danger of injuring the patient.Stop the intervention for safety reasons if the image is blurred.Check the image quality of the endoscope before use (section 8.2).Section 8.2 function check.Check image quality and light output in conjunction with the system components.- check the glass surfaces for any deposits.- deposits on the glass surfaces can cause a spotted or blurred field of view and hence impair light transmission considerably.- clean the glass surfaces with a swab soaked with alcohol (wooden swab carrier, not metal or plastic) and hard-to-remove deposits with a suitable instrument cleaner.- check the light output without the system components.- hold the distal end of the endoscope towards a light source.- broken fibers appear as black dots at the cold-light connector.If approx.30% of the fibers are broken, the light output is no longer sufficient.Potential hazard due to degradation of image transmission were considered in the risk assesment a1, rev.05 reusable rigid telescopes with and without working channel with the corresponding extend of damage and probability of occurrence, and were rated as acceptable risk.This assessment is still valid even considering the current case.In view of rw gmbh, an user error led to the cancellation of the surgery.The telescope shall have been checked before and after each use.Further checks shall also performed during reprocessing the instrument.If all these checks would have been performed according to the manufacturer's instructions, the leaking telescope should not have been used in the treatment at all.Rwmic is submitting this report on behalf of richard wolf gmbh.A new report will be submitted if new information becomes available.Rw gmbh considers this mdr closed.
Event or Problem Description
See manufacturers narrative for results of the device investigation.

• Brand Name: PANOVIEW
• Common Device Name: TELESCOPE 12° Ø 4MM WL 297MM RIGID
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 11895248
• Report Number: 9611102-2021-00021
• Device Sequence Number: 14217889
• Product Code: GCM
• UDI-Device Identifier: 04055207018804
• UDI-Public: 04055207018804
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K993103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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
• Operator of Device: Health Professional
• Device Model Number: 8654431
• Device Catalogue Number: 8654.431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 06/25/2021
• 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