MAUDE Adverse Event Report: RICHARD WOLF GMBH E-LINE; URETERORENOSCOPE 12° 8/9.8FR WL 430MM

Model Number	8703524
Medical Device Problem Codes	No Display/Image (1183); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A distributor has informed richard wolf gmbh an issue regarding a ureterorenoscope 12° 8/9.8fr wl 430mm, part id: 8703524, serial # (b)(6).According to the received information, during a diagnostic ureteroscopy/ureterorenoscopy (urs) examination, the distal end of the scope bent and as a result, the monitor failed to display the image.Consequently, the planned surgery for the left mid ureteral area was cancelled.
Additional Manufacturer Narrative
The following fields have new information: h6 (health effect impact code, type of investigation, investigation findings, and investigation conclusions.The ureterorenoscope 12 8/9.8fr wl 430mm, part id: 8703524, serial#: (b)(6), was investigated at rw gmbh.Visual examination revealed that the cladding tube was severely kinked and crushed distally at the taper.Such damage is usually caused by mechanical overload.The exact circumstances that led to the deformation of the sheath and ultimately to the termination of surgery were not reported by the user.The user stated that there were no negative consequences for the patient.The ureterorenoscope 12 8/9.8fr wl 430mm, part id: 8703524, serial#: (b)(6) was produced on 05/aug/2022.The production order consisted of 10 ureterorenoscopes.In the review period of 01/jan/2020 and 19/jun/2023, there were 6 complaints regarding bent and or kinked sheathing tube.The investigation of the cases revealed that the damage caused to the product was due to a mechanical overload.There were no product or production-related root cause identified.The ifu ga-d 352 i usa / 2012-11 v4.0 / 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.Additionally, the ifu states that the products have only limited strength.Applying excessive force will lead to damage, impair the function and 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.The subject issue is present in the risk management file a 1- reusable rigid optics with and without working channel, rev.05.The overall probability of occurrence for this issue is consistent with previously defined levels and the overall risk of the device remains in the acceptable category.

• Brand Name: E-LINE
• Common Device Name: URETERORENOSCOPE 12° 8/9.8FR 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: oliver ehrlich ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 17239921
• Report Number: 9611102-2023-00040
• Device Sequence Number: 15161264
• Product Code: FGB
• UDI-Device Identifier: 04055207020081
• UDI-Public: 04055207020081
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K963855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2023

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: 8703524
• Device Catalogue Number: 8703.524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2022
• 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