MAUDE Adverse Event Report: RICHARD WOLF GMBH BOA VISION; SENSOR-URETERORENOSCOPE 8.7FR WL 680MM FLEXIBLE

Model Number 7355071

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/26/2019

Event Type  malfunction  

Manufacturer Narrative

The user facility confirmed that there was no illness or injury to the patient or personnel due to this issue.The issue caused a delay in the procedure that caused the patient to be under anesthesia longer than necessary.User facility returned the device to rwmic on january 06 2020, and the evaluation was completed on march 13th 2020 by the manufacturer rw gmbh.The device appeared to be used but the complaint condition could not be verified.A laser fiber was able to go through the channel without difficulty.Visual and functional testing were performed using controller equipment # 5225108 for leak testing.It was determined that the cause of the damaged proximal tube is due to mechanical influences.There was no chemical interaction (change) at the master bond adhesive site.Compliance with the reprocessing methods recommended in ifu gs-j050 and the specific ga-d370 recommended by the manufacturer.Complaint was found not to be valid since it does not correspond the delivery condition.However, a replacement device was sent to the user facility.The root cause was determined to be user-handling issues.A manufacturing defect was not identified.Device labeling ga-d370 and ga-j050 were reviewed for patient code and device codes, see below: ga-d370: page 13: caution! careful if the instrument tip (4) is blocked by external influences (e.G.Limited free space)! this may damage the controls.If the instrument tip (4) is blocked, do not use force when actuating the control lever (12).Move the instrument tip (4) to a position that allows control without applying force.Caution! danger of destroying the working channel by the sharp distal end of the laser fiber! the stronger (stiffer) the laser fiber the bigger the danger that the sharp distal end of the laser fiber destroys the working channel.The laser fiber must therefore be inserted in the working channel (1) or retracted from the working channel (1), respectively, carefully and only with straight instrument sheath (5) and when the instrument tip (4) is straight (0° position).Caution! danger of destroying the instrument by a broken laser fiber! if the instrument tip is angled (small bending radius) this increases the danger of a fracture of the laser fiber and even more so with increasing laser fiber diameter.A fracture of the laser fiber within the instrument channel while the laser energy is active will immediately destroy the instrument.In the latter case, switch off the laser energy immediately.Use only highly flexible laser fibers with a maximum permissible laser fiber diameter of 272 ga-j050: to remove any clogging and residues, carefully clean all channels with suitable cleaning brushes (see table in section 6.4).Important! cleaning the suction channel (7)! introduce the short cleaning brush into the valve holder (6) as far as it will go, do not insert forcibly.Pull the cleaning brush back and forth in the suction channel.Important! cleaning the working channel (1) / laser fiber channel (13)! introduce the long cleaning brush only from proximal to distal, do not introduce forcibly into the working channel (1) / laser fiber channel (13).Do not pull the cleaning brush back and forth in the working channel (1) / laser fiber channel (13) as this can cause damage.Guide the cleaning brush only in one direction through the working channel (1) / laser fiber channel (13) and pull back only after the brush head has fully emerged at the distal end.Rwmic considers this matter closed.However, in the event rwmic receives any additional information a follow up report will be submitted to fda.- attachment: [ga-d370 usa_3.0 (15-0069).Pdf, ga-j050 usa_5.0 (13-0221).Pdf].

Event Description

On december 26th 2020, the user facility reported the following to richard wolf medical instruments corporation (rwmic): the scope was just transferred into the facility.It was processed by the central processing departament.It was opened up for the first case and we were unable to get a 200 laser fiber through the tip of the scope.The laser fiber was removed and a guide wire was then placed through the scope again to see if there was an issue with the scope.The guide wire went through fine.The guide wire was then removed, and the 200 laser fiber was tried one more time.It still wouldn't go through the distal tip of the scope.It was removed from the field and then pressure tested by myself (b)(6) where it passed the test.I took the scope to decontam to see if i could get a cleaning brush through, to where i found it was difficult to get it to pass through the distal tip.(b)(6) then checked the scope out for him self and he said it seems fine.Tried to use the scope again and it still was unable to pass a 200 laser fiber through.Will the device be returned? yes.Was the device being used during a procedure 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.Did the delay put the patient at risk? yes.Was there a similar back-up device available for use? yes.Was the scheduled procedure completed? yes.

• Brand Name: BOA VISION
• Type of Device: SENSOR-URETERORENOSCOPE 8.7FR WL 680MM FLEXIBLE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• Manufacturer Contact: heiko seider-biedermann ; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 10279685
• MDR Text Key: 242470080
• Report Number: 1418479-2020-00004
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04055207054840
• UDI-Public: 04055207054840
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 07/15/2020

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: 7355071
• Device Catalogue Number: 7355.071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/15/2020
• Distributor Facility Aware Date: 12/26/2019
• Date Report to Manufacturer: 07/15/2020
• Initial Date Manufacturer Received: 12/26/2019
• Initial Date FDA Received: 07/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1