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

Model Number 7315006

Device Problem Optical Distortion (3000)

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

Event Date 10/23/2022

Event Type  malfunction  

Event Description

The user reported the following: the scope is dead (after a few uses).User cancelled the cystoscopy, no function on the cystoscope.User has to plan a new date for cystoscopy.

Manufacturer Narrative

During the inspection of the sensor-cystoskop 16,2ch nl 400mm 7315006, serial # (b)(4) by richard wolf gmbh, it was determined in accordance with test instructions that the scope has slight image disturbances.Otherwise, the sensor cystoscope is in good condition and has no external damage.After opening the housing, there were no signs of moisture penetration (as-new appearance of the electronic and mechanical components).After a period of use approx.9 months and the scope in a good condition and there is no moisture in the optical system, it is assumed that the scope has failed sporadically.The sensor cystoscope was produced on 26/apr/2023, the production order consisted of 5 sensor cystoscopes.The subject sensor cystoscope was delivered to the customer on (b)(6) 2023.In the review period of (b)(6) 2020 and (b)(6) 2023, there was no similar complaint regarding the image failure.The ifu ga-d389 / en-us / 2020 v3.0 / pk17-8970 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 - reusable flexible video 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.

• Brand Name: MAMBA VISION
• Type of Device: SENSOR-CYSTOSCOPE 16.2FR WL 400MM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438, knittlingen, germany ; GM
• Manufacturer Contact: heiko seider-biedermann ; pforzheimer strasse 32; d-75438, knittlingen, germany ; GM
• MDR Report Key: 16387647
• MDR Text Key: 309986362
• Report Number: 9611102-2023-00005
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04055207063477
• UDI-Public: 04055207063477
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K051176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/16/2023

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
• Device Operator: Other
• Device Model Number: 7315006
• Device Catalogue Number: 7315006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2023
• Initial Date FDA Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other