MAUDE Adverse Event Report: RICHARD WOLF GMBH; FIBER-CYSTOSCOPE 15FR WL 400MM FLEXIBLE

Model Number 7305001

Device Problem Flaked (1246)

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

Event Date 11/23/2021

Event Type  malfunction  

Manufacturer Narrative

Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.Rwmic considers this mdr open.Rwmic will submit a follow up report after the device evaluation has been completed and/or new information (user facility) becomes available.

Event Description

It was reported to richard wolf by the doctor noticed when using this scope and was viewing the patients bladder, she described what looked like to her was metal shavings in the bladder.Then, when she removed the scope from the patient's bladder the scope was laid on white sheet and black fluid was observed dripping out of the end of the scope.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? no.Did the delay put the patient at risk? no.Was there a similar back-up device available for use? yes.Was the scheduled procedure completed? yes.Follow-up with the user facility: according to the complaint initiator (12/8/21), "i don't know that this happened while we were treating patients.It was flushed after its soak and the ma immediately reported the black material flushing out and we took it out of service for the day." additionally from the sales rep when asked if he knew if the delay put the patient at risk, he said that "as far as i know they was not a delay in completed the procedure".

Event Description

The purpose of this submission is to report: results of the device evaluation/investigation; additional details received from the user facility.One other statement provided by the user facility: "i spoke to the doctor, she said the pt was female and cannot remember her dob.She doesn't believe there was a risk to the pt but can't say for sure because we are unaware of what the material being flushed through was.Device investigation: the device was evaluated using visual and functional means.The reported condition "black fluid dripping out of scope/metal like shavings in the bladder" was confirmed.Findings: working channel leaks from tip, moisture in optic system.There is no evidence of metal shedding, no particles nor foreign matters inside working channel.Deflection stiffness is very likely caused by the moisture in optic system.Leakage of working channel resulted in graphite spill that looked like a black fluid.Graphite powder is used at the vertebra to lubricate the deflection and move it smoother and as well when the shaft is manufactured for lubricating all its components (picture bundle, working channel and illumination fiber lights).Damage occurred either during reprocessing when a cleaning brush was used inside the working channel and this created a tear inside the working channel or during a procedure with an instrument prematurely opened inside the scope that created the tear.Probable root cause: reprocessing, user error.In order to repair the scope a shaft replacement is required.The device was repaired; shaft replaced.

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 new information and/or changed information.Device labeling was reviewed for patient code and device codes, see below: patient code: not applicable, no patient problem was reported.Device code: ifu was reviewed.The ifu (ga-s006 usa_3.0) contains: important! do not use metal brushes for cleaning.Important! when using a cleaning gun make sure that the rinsing pressure is not higher than 7.25 psi.Use a pressure reducing valve if necessary.The ifu contains directions on cleaning the working channel: important! cleaning the working channel (13)! insert the long cleaning brush into the working channel (13) only from the proximal end to the distal end without applying any force.Do not pull the cleaning brush back and forth in the working channel (13) as this can result in damage to the working channel of the fiberscope.Guide the cleaning brush through the working channel (13) only in one direction and pull back only after the brush head has been fully exposed at the distal end.Also included in the ifu is a table that shows which brushes should be used.Rwmic considers this mdr closed.Should rw receive new information, a follow-up report will be submitted.

• Brand Name: NA
• Type of Device: FIBER-CYSTOSCOPE 15FR 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: 12983803
• MDR Text Key: 289508480
• Report Number: 1418479-2021-00054
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04055207013656
• UDI-Public: 04055207013656
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/17/2021

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: 7305001
• Device Catalogue Number: 7305.001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/30/2021
• Initial Date FDA Received: 12/13/2021
• Supplement Dates Manufacturer Received: 12/17/2021
• Supplement Dates FDA Received: 01/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2019
• 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
• Treatment: N/A PER USER FACILITY.
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White