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

Model Number 7355071

Device Problems Loss of or Failure to Bond (1068); Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

The user facility representative reported that sensor-ureterorenoscope 8.7fr wl 680mm, part no.7355071, serial no.(b)(4), deflection cover bunched up and the surgeon could not pull the scope through the access sheath and ureter.The primary surgeon needed to call a partner who was able to help remove the scope.The secondary urology (the specialist) didn't seem upset about the issues.I am not sure why the deflection cover bunched up.Additional information was received from the user facility representative on january 20, 2023.According to the received information, there was a delay of 45 minutes in the procedure and a follow-up procedure is necessary to complete the scheduled and planned treatment.

Manufacturer Narrative

New information: b4, g3, g6, h2, h3, h6 (type of investigation, investigation findings, investigation conclusions), h7, and h10.Corrected data: h4.Patient information: the user facility was contacted several times in an effort to collect patient information.The sales representative confirmed no further patient information was obtainable.Device evaluation: the sensor-ureterorenoscope 8.7fr wl 680mm, part no.7355071, s/n (b)(6), was investigated in the responsible department.The visual and functional investigation revealed that the distal hose was overlapped.The probable root cause of the findings cannot be exactly determined, because no information is available how many times the reported device was used, reprocessed by the user facility since delivery and which reprocessing method was used.However, the damage pattern indicates improper handling during reprocessing.The sensor-ureterorenoscope 8.7fr wl 680mm, part no.7355071, serial # (b)(6) was manufactured on 23/sep/2020.No issues were identified during production, no further complaints were received regarding this issue.The ifu ga-d396 / en-us / 2020-11 v1.0 / pk20-0024 contains several instructions of visual and functional checks prior and after each use in section 8 checks.Furthermore, the user is advised about the proper handling of the device in section 9 processing procedure.The subject issue of functional impairment/traumatizing geometry as well as hazard due to working conditions and restricted freedom of movement is present in the risk management file a4: 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: BOA VISION
• Type of Device: SENSOR-URETERORENOSCOPE 8.7FR WL 680MM
• 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: zsófia bartholome-nagy ; pforzheimer strasse 32; d-75438, knittlingen, germany ; GM
• MDR Report Key: 16385090
• MDR Text Key: 309970943
• Report Number: 9611102-2023-00003
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 05/04/2023

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: Other
• Device Model Number: 7355071
• Device Catalogue Number: 7355071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2023
• Initial Date FDA Received: 02/16/2023
• Supplement Dates Manufacturer Received: 04/18/2023
• Supplement Dates FDA Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1