MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP. VIPER; FIBER-URETERORENOSCOPE 9.6FR WL 680MM

Model Number	7325071
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility has informed richard medical instruments corp.(rwmic) of an issue regarding a fiber-ureterorenoscope 9.6fr wl 680mm, part id: 7325.071, serial # (b)(6).According to the received information, the physician was handed the scope, he inspected it and noticed that the tip appeared larger "like a piece of tape was placed on it during repair, and it will not fit into the access sheath if i was to try it".Scope was not used and was taken out of circulation immediately.There is no report of injury to the patient or other personnel.However, the reported issue caused a 5 minute delay in the middle of a cystoscopy, ureteroscope, laser litho and stent exchange procedure when the physician identified the reported issue and inspected the scope.The physician elected not to use the device.As a result, the scheduled procedure was not completed.
Additional Manufacturer Narrative
The following fields have new information: b4, d9 (date returned to manufacturer), g3, g6, h2, h3, h6 (type of investigation, investigation findings, and investigation conclusions), h7, and h10.Patient information: the user facility was contacted in an effort to collect patient information.The initial reporter provided no patient information.Device evaluation: the fiber-ureterorenoscope 9.6fr wl 680mm, part id: 7325.071, serial # (b)(6), was investigated at richard wolf medical instruments corporation (rwmic).The visual and functional evaluation revealed that the distal hose was overlapped.The probable root cause of the findings cannot be exactly determined, because no information is available how many times the reported device was used or reprocessed by the user facility since delivery.Also, which reprocessing method was used.However, the damage pattern indicates improper handling during reprocessing.Additionally, it is most likely that during the improper reprocessing, the distal hose could lose the elasticity and overlapping the head making impossible to fit in the access sheath.The instrument 7325.071, serial # (b)(6) was produced on 10/apr/2017.The examination of the production documents did not reveal any anomalies or deviations.A review of the last 3 years has shown that there are a total of 7 complaints with similar allegations.However, only 3 devices were evaluated and the rest were not returned to the manufacturer.2 of the devices evaluated including this case revealed the similar root cause.In general, the user is advised in the associated instructions for use, ifu ga-d347 / en / us / v8.0 / 2022-10 / pk22-0616 under chapter 8.1 that a visual check must be carried out before and after each use, in particular its distal area for damage e.G.Cracks of the outer jacket / perforations.Also chapter 9.6 reprocessing sequence emphasizes the danger of creasing of the outer jacket.To avoid wrinkling or folding over of the plastic outer coating apply reduced pressure in the distal area of the flexible endoscope while wiping or handling.The problem is assessed as acceptable in the risk management file a3: "reusable flexible telescopes with and without working channel" rev.05 under hazard no.5 "hazard due to unusable product" under "handling-related causes".The overall probability of occurrence of this problem remains at the previously defined level, extent of damage medium probability of occurrence unlikely.The overall risk of the product remains in the "acceptable" category and does not need to be adjusted.

• Brand Name: VIPER
• Common Device Name: FIBER-URETERORENOSCOPE 9.6FR WL 680MM
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP.; 353 corporate woods parkway; vernon hills IL 60061
• Manufacturer (Section G): RICHARD WOLF MEDICAL INSTRUMENTS CORP.; 353 corporate woods parkway; vernon hills IL 60061
• Manufacturer Contact: philip umali ; 353 corporate woods parkway; vernon hills, IL 60061 ; 8479131113
• MDR Report Key: 18266994
• Report Number: 1418479-2023-00022
• Device Sequence Number: 3893946
• Product Code: FAJ
• UDI-Device Identifier: 04055207013694
• UDI-Public: 04055207013694
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K980401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2024

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?: No
• Operator of Device: Other
• Device Model Number: 7325071
• Device Catalogue Number: 7325.071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2023
• Supplement Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male