MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. URETERO-RENO FIBERSCOPE

Model Number URF-P7

Device Problem Break (1069)

Patient Problems Abrasion (1689); Foreign Body In Patient (2687); Unspecified Kidney or Urinary Problem (4503)

Event Date 11/22/2022

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

A company representative reported to olympus on behalf of a user facility that the bending section of the uretero-reno fiberscope had broken in the patient's ureter.Indication for initial surgical treatment was a 2 cm stone.A fiber laser was used to spray the stone without difficulty.Upon removal of the uretero-renoscope, it blocked the iliac ureter and was impossible to remove.After multiple attempts, the scope was removed but 10 cm of the distal end of the uretero-renoscope remained in the upper left ureter next to the iliac vessels.A catheter was placed parallel to the foreign body to drain the kidney.The lower ureter was explored and scratched mucosa was found with a mucous flap.The surgeon decided not to attempt to remove the foreign body to avoid further damage and a bladder catheter was placed.Three days later, the patient underwent a 2 hour intervention for extraction of the foreign body in the left ureter.A transperitoneal laparoscopic approach was utilized to access and dissect the left ureter.The foreign body was located in the ureter just above the iliac vessels and was removed.A "jj loop" (a double pigtail ureteral stent) was placed; the position was checked by pyelography through the ureteral probe and was found to be well looped into the kidney.The catheter was removed and the jj loop was left in place.No blood loss occurred.Post procedurally, the patient was transferred to another unit.Their hospital stay was extended by 6 days.The plan of care for the patient was to keep the jj loop in place for 3 months with regular monitoring.Additional information has been requested, if received, a follow up report will be sent.

Manufacturer Narrative

Upon evaluation of the returned device, significant burning/melting of the distal end was observed, which was thought to have occurred during use of the laser.Additionally, it was found that the bending section was broken at 63 mm from the distal end.The cross-sectional observation of the broken part indicates that the bending section was broken due to twisting physical stress.The components were twisted in shape.The cross-sectional surface shows that the bending section was not cut by sharp edge, but rather twisted and broken off.Due to the level of damage, the angle wires were locked in the bending tube.It was unable to be determined if the wire issues occurred during the procedure.Specific to the a-rubber portion proximal side (endoscope side), significant deformation was identified at about 72 - 74mm from the distal end.The a rubber around the deformation was intact; there was no pin hole nor incise (cut).Nothing protruded from the a-rubber.After the a-rubber removal, the significant deformation of bending tube was then observed.Specific to the a-rubber on the distal side, one minor incise and two b tube deformations were observed.The shape of incise looked the same as the skeleton of b tube.The minor incise was about 48 mm from the distal end; the minor deformation of b tube was observed at around 51 mm and 60 mm from the distal end.The root cause cannot be determined at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.Humidity was also found inside the full device.The humidity was located in the ns-unit, control body unit and eyepiece, which resulted in a high level of corrosion.

Event Description

Additional information from the surgeon was obtained.The surgeon hypothesized that the reason as to why the device could not be withdrawn was that the junction between the bending section and the rigid portion became deformed during the procedure.This caused an increase in size, preventing its removal.When the surgeon was attempting to extract device (multiple times), they had to rotate the device in one direction and then in the other direction to try to get it down into the ureter.It was clarified that the access sheath was not introduced during the case at all.The surgeon also stated that they did not "shoot" the laser when the distal end was not out of the endoscope and that each "shot" was done with a view of the distal d of the laser fiber.The surgeon could not exclude that the fiber had a defect in the endoscope channel which may have lead to damage of the endoscope.When asked if a pre procedure check was done, the surgeon stated that a post-procedure leakage check was performed before pre-disinfection (after each use).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation, the reported event was likely caused by the user rotating the device while the device was difficult to be withdrawn from the patient, which applied irregular stress to the bending tube and led to breakage of the tube.Furthermore, the user may have not stopped rotating the device even though the bending tube was broken, which led to cut/torn bending section cover, a-wire, biopsy channel, light guide, and image guide due to applied irregular stress.As a result, the distal end of the device remained in the patient¿s body.However, it could not be determined that a device abnormality occurred.Therefore, the root cause of the reported event could not be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16032876
• MDR Text Key: 305980252
• Report Number: 9610595-2022-05948
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K181451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: URF-P7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 01/25/2023; 04/11/2023
• Supplement Dates FDA Received: 01/31/2023; 05/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2020
• 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: FIBER LASER.
• Patient Outcome(s): Hospitalization; Required Intervention