MAUDE Adverse Event Report: RICHARD WOLF GMBH PANOVIEW PLUS HD; DISCOSCOPE 25° Ø 5.9MM SL 122MM

Model Number 892107253

Device Problem Poor Quality Image (1408)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/06/2023

Event Type  Injury  

Event Description

Richard wolf medical instruments corporation (rwmic) received a medwatch report, mw5118856, regarding an issue with a discoscope 25° ø 5.9mm sl 122mm, part id: 892107253, serial: (b)(6).The medwatch report, mw5118856, states that the "scope was blurry during a case, causing a delay in case and increased anesthesia time.Sterilization issues ruled out (no leaks).Customer stated the scope had recenly been repaired in march 2023 for same issue." according to the initial reporter, the reported issue caused a 20 minute delay in the procedure while the back-up device was retrieved to complete the scheduled procedure.The reporter stated the delay in the procedure resulted in the patient being at potential risk due to the increased anesthesia time.There was no additional treatment or procedure needed.There is no report of injury to the patient or other personnel as a result of the reported issue.

Manufacturer Narrative

The following fields have new information: b4, g3, g6, h2, h3, h6 (type of investigation, investigation findings, and investigation conclusions).The discoscope 25° ø 5.9mm sl 122mm, part id: 892107253, serial# (b)(6) was investigated at rw gmbh.The investigations revealed that the soldered seam between the proximal gl and the funnel holder sporadically leaks.Therefore moisture could penetrate inside the optical system and as a result of that, the image became blurred.Further investigations showed that the cladding tube was slightly bent, dented and scratched with the following error - a conchoidal fracture at a triangular prism (dp) 14005051 in the optical system as a result of the bending.Additionally, distal optical fiber/ cementation was thermally stressed (mechanical overload).The light emitting surface is discolored due to insufficient cleaning and thermal effects.Therefore, user error has been determined to be the root cause of the reported event.The discoscope 25° ø 5.9mm sl 122mm, part id: 892107253, serial#: (b)(6) originates from the production order: (b)(4) with a batch size of (b)(4) pieces on 06/jun/2018.The examination of the production documents did not reveal any anomalies or deviations in the serial number.The customer statement "the scope had recently been repaired in march 2023 for same issue." could not be traced.No comparable cases of this type 892107253 have been registered in the period under consideration.In general, the user is advised in the associated instructions for use ga-b 223 /usa/ 2012-10 v5.0 / eco 2012-0519 under chapter 7 that a visual and functional check must be carried out before and after each use, among other things with regard to the image and light quality.Possible image impairments can be easily detected if these instructions are followed.In our risk analysis a1 rev.05, 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 and assessed with an acceptable risk.

• Brand Name: PANOVIEW PLUS HD
• Type of Device: DISCOSCOPE 25° Ø 5.9MM SL 122MM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• Manufacturer Contact: marco bruxmeier ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 17397735
• MDR Text Key: 319854805
• Report Number: 9611102-2023-00047
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 04055207035092
• UDI-Public: 04055207035092
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 08/09/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 892107253
• Device Catalogue Number: 892107253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2023
• Initial Date Manufacturer Received: 07/12/2023
• Initial Date FDA Received: 07/26/2023
• Supplement Dates Manufacturer Received: 08/03/2023
• Supplement Dates FDA Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 76 KG