MAUDE Adverse Event Report: RICHARD WOLF GMBH E-LINE; URETERORENOSCOPE 5° 6/7.5FR WL 430MM

Model Number	8702534
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The examination has revealed that moisture has penetrated into system at the sealing ring.The ureterorenoscope 5° 6/7.5fr wl 430mm, part id: 8702534, serial # (b)(6), was produced on (b)(6) 2022 in a lot of (b)(4) pieces.Until today, this is the only s/n (b)(6) from this lot which was claimed with this error pattern.The defect is considered as a sporadic failure.In the last three years, a total of 6 complaints were processed for this type, which were also classified as sporadic failures.At the same time, (b)(4) types were sold worldwide.Based on this data, we do not see any fundamental problem, the instrument corresponds to the current state of the art.The ifu ga-d 352 /usa/ 2012-11 v4.0 i eco: 2012-0540 contains several descriptions of visual and functional checks which serve to detect faults prior to use on patient in section 7 use and section 8 checks.In additional, the ifu states that there must always be an operable comparable device or a conventional system on hand.The subject issue of image failure is present in the risk management file a1 - reusable rigid optics 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.
Event or Problem Description
The user facility has informed richard wolf gmbh of an issue regarding a ureterorenoscope 5° 6/7.5fr wl 430mm, part id: 8702534, serial number # (b)(6).Surgery planned on august 5, 2023, resolution of patient case with ureteral lithiasis, ureteral lithotripsy surgery is planned using richard wolf ureterorenoscope 5° 6/7.5fr.According to the initial reporter, the procedure begins, perceiving poor image quality at the beginning of the procedure, with the presence of an external halo that reduces the field of vision, making maneuvers within the ureter difficult.An attempt is made to perform lithotripsy with a pneumatic lithotripter; due to vision difficulties, it is decided to suspend procedure and reschedule the case until a new work item is available, exposing the patient again to another anesthetic event and another hospitalization.There was a time delay about 90 minutes.

• Brand Name: E-LINE
• Common Device Name: URETERORENOSCOPE 5° 6/7.5FR WL 430MM
• 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: valentin felsing ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 17920799
• Report Number: 9611102-2023-00058
• Device Sequence Number: 19578860
• Product Code: FGB
• UDI-Device Identifier: 04055207020036
• UDI-Public: 04055207020036
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 10/12/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 8702534
• Device Catalogue Number: 8702.534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2022
• 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: Unknown