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

Model Number 7315001

Device Problems Erratic or Intermittent Display (1182); Unexpected Shutdown (4019)

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

Event Date 10/19/2021

Event Type  malfunction  

Event Description

It was reported to richard wolf: the device was delivered to the customer on (b)(6) 2021.The first time it was used the picture on the monitor would flicker and then eventually shut off.The scope was working well for the first few minutes and then the issues started happening.Additional details: will the device be returned? yes.Was the device being used on a patient when the reporting issue occurred? yes.Was there any injury or illness to the patient due to the reported issue? no.Was there any injury or illness to any other personnel due to the reported issue? no.Did the issue cause a delay in the procedure being performed? yes.Did the delay put the patient at risk? unknown.Was there a similar back-up device available for use? no.Was the scheduled procedure completed? no.The following questions were asked of and answered by the sales rep regarding the delay in the procedure:.How long was the delay? long enough for them to abort the procedure.What actions were being done during the delay? they pulled out the paddle and cleaned it and re inserted it.Did the patient require any additional treatment during the delay or will require another procedures as the result of the delay? the patient will require another appointment to finish the procedure.What was the patient's outcome? the procedure was not finished.

Manufacturer Narrative

(b)(4).Rwmic considers this mdr open.Rwmic will submit a follow up report after the device evaluation/customer contact has been completed and/or new information becomes available.

Manufacturer Narrative

Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.Follow-up report #1 is to provide fda with missing information, new information, and changed information.Missing information: user facility, three attempts were made directly to user facility, one attempt through the sales rep in an effort to collect patient and user information.As of 12/15/2021,the only information received from the user facility was to correct misinformation about the procedure.New information: the following fields have new information: b5, g2-3, g6, h2, h6, h10.Changed information: the following fields have changed information: h3.Rwmic considers this mdr closed.Should rwmic receive new information (user facility respond to inquiry) a follow-up report will be submitted.

Event Description

The purpose of this submission is to report the results of the device investigation and the response from the user facility.Device evaluation: the device was evaluated using visual and functional means.The reported condition, flickering picture then shutoff, was confirmed.Findings: no image, electronic unit within the device is not functional.Unable to determine why the component is not working.When electronic unit is exchanged, the image appears.The device was repaired, the shaft and senor were replaced.Response from the user facility: we received a correction from the user facility on the procedure.We had previously been told, by the sales rep, that the procedure had to be aborted.According to the user facility, "the procedure wasn't aborted, the provider was aborted for that patient, provider was able to continue with a different scope." no other information was provided.The medwatch questionnaire that was attached to the email was not returned.

• Brand Name: MAMBA VISION
• Type of Device: SENSOR-CYSTOSCOPE 16.2FR WL 400MM FLEXIBLE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• Manufacturer Contact: heiko seider-biedermann ; pforzheimerstr. 32; knittlingen 75438 ; GM 75438
• MDR Report Key: 12771606
• MDR Text Key: 288135503
• Report Number: 1418479-2021-00049
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04055207063460
• UDI-Public: 04055207063460
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/15/2021

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 Operator: Health Professional
• Device Model Number: 7315001
• Device Catalogue Number: 7315001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2021
• Initial Date FDA Received: 11/08/2021
• Supplement Dates Manufacturer Received: 12/15/2021
• Supplement Dates FDA Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2019
• 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