MAUDE Adverse Event Report: RICHARD WOLF GMBH COBRA VISION; SENSOR-URETERORENOSCOPE 9.9FR WL 680MM FLEXIBLE

Model Number	7356071
Medical Device Problem Code	Vibration (1674)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
This mdr is being submitted as part of a retrospective review of all 2016-2017 complaint files that rwmic is completing.Recently the complaint specialist determined a re-assessment of the mdr decision for this complaint was needed and that for this complaint, due to a delay in the procedure being performed that resulted in patient being at risk, an mdr should be filed.Previously in 2017, the complaint specialist at that time, determined an mdr was not needed due to "no injury to patient or staff.Backup device readily available for use.Minimal delay, minimal risk to patient.Procedure completed as scheduled." facts of the case as reported to richard wolf by the user facility: "distal tip of scope highly sensitive to vibrations of the laser, event turning down the laser "wattage" the image did not improve.Additional information: will the device be returned? yes was the device being used during a procedure when the issue occurred? yes specifically, was the device being used on a patient when the issue occurred? yes was there any injury or illness to patient or other personnel due to issue? no did the issue cause a delay in the procedure being performed that put the patient at risk? yes was there a similar back-up device available for use? yes.Was the scheduled procedure completed? yes.How was the patient anesthetized? general? this malfunction was low risk to the patient; no issues reported to patient, no other cases reported with similar issue in 2017.No contact information was provided in the file for the user facility.Contact is being attempted through the sales rep.See manufacturers narrative for device investigation results.
Additional Manufacturer Narrative
Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.Device investigation results: complaint condition was verified test equipment used: controller (b)(4) leak tester.Physical findings: leakage in the housing/cover.Conclusion: the adhesive bond to the housing/cover was not optimally executed.Because of that, moisture penetrated inside the instrument and has damaged the senor (bad picture).Action required: repair exchange required.To improve the adhesive bond to the housing/cover, a product change pk17-8900 has been started.Rwmic considers this mdr closed.Should rw receive new information, a follow-up report will be submitted.

• Brand Name: COBRA VISION
• Common Device Name: SENSOR-URETERORENOSCOPE 9.9FR WL 680MM 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: 13232269
• Report Number: 1418479-2021-00057
• Device Sequence Number: 4330333
• Product Code: FGB
• UDI-Device Identifier: 04055207054864
• UDI-Public: 04055207054864
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K183188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/22/2017

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: 7356071
• Device Catalogue Number: 7356071
• Device Lot Number: 5000328980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2015
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown