MAUDE Adverse Event Report: RICHARD WOLF GMBH MAMBA VISION; SENSOR-CYSTOSCOPE 16.2FR WL 400MM

Model Number	7315006
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that at the beginning of the surgical procedure the distal light of the cystoscope failed.The treatment was unable to be completed and had to be cancelled.There is no report of injuries to the patient or other third parties.
Additional Manufacturer Narrative
The sensor-cystoscope was examined in the specialist department, and the following was found: - the insertion tube is crushed at 17 cm.- distal tube is worn.Consequential damage: failure of both leds.The sensor-cystoscope type 7315006 with sn: (b)(6) comes from production batch 1574419 and was manufactured on march 22, 2024, with a batch size of 5 pieces.The inspection of the flow chart did not reveal any abnormalities.The device was delivered to the customer on june 12, 2024.Causes: mechanical influences such as jamming of the fiberscope tip led to the crushing.Mechanical influences can occur during the preparation, transport, and handling of the instrument.To avoid such damage, the user is informed in the instructions for use, ifu ga-d389, chapter 7, about the limited stability of the products.Excessive force will cause damage, impair function, and thus endanger the patient.Risk assessment: in general, the user is instructed in the corresponding instructions for use, ifu ga-d389, chapter 8, that a visual and functional check must be carried out before and after each use.Possible damage and leaks of the above type can be easily detected by hospital staff if these instructions are followed.In our risk analysis a4-2, manufacturing-related, handling-related, and design-related hazards with regard to functional impairment as well as risks due to an unusable product with the corresponding severity and assumed probability of occurrence were considered and assessed as an acceptable risk.No comparable cases of this type were reported during the 3-year period under review.As the investigation of the current complaint did not reveal any new risks, the risk assessment remains valid, even taking into account the possibility of recurrence.The inspection of the sensor-cystoscope did not reveal any systematic defects from a manufacturing or design perspective.Based on these handling errors, no measures are necessary.

• Brand Name: MAMBA VISION
• Common Device Name: SENSOR-CYSTOSCOPE 16.2FR WL 400MM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany 75438 ; GM 75438
• 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: 22579645
• Report Number: 9611102-2025-00038
• Device Sequence Number: 11884347
• Product Code: FAJ
• UDI-Device Identifier: 04055207063477
• UDI-Public: 04055207063477
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K051176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 07/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 7315006
• Device Catalogue Number: 7315006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown