MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO FIBERSCOPE; FLEXIBLE FIBREOPTIC URETERORENOSCOPE

Model Number URF-P6R

Device Problem Entrapment of Device (1212)

Patient Problems Device Overstimulation of Tissue (1991); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 04/13/2022

Event Type  Injury  

Event Description

The physician reports the patient was a young healthy male undergoing an ureteroscopy for removal of ureteral stones.The patient had multiple stones impacted in the mid-ureter.The physician was unable to place a guide wire due to the impacted stones.Due to this, a ureteral stent was placed.The scope was advanced to the mid ureter.Stones were lased and removed.At the conclusion of the procedure, the physician attempted to remove the scope and was unable to because the ureter had begun to spasm due to the extensive manipulation.Measures taken to relax the ureteral spasms (so the scope could be removed) included: gentle steady traction, toradol, narcotic pain medications, and draining the bladder.None of these measures helped to relax the ureter so the scope could be removed.Thinking that the extra manipulation of applying gentle steady traction might be contributing to continued ureteral spasm, the physician stopped the traction and allowed the patient to "rest" still under anesthesia, for around 30 minutes.This rest allowed the ureter to relax and the scope was removed without resistance.The difficulties with the scope removal added approximately 90 minutes to the procedure time.There were no adverse effects to the patient as a result of the extended procedure.There were no adverse effects to the patient as a results of the scope being "stuck" inside the patient for approximately 90 minutes.The patient's current condition is good.The scope is being returned.The physician stated there were no abnormalities in the appearance of the scope tip prior to or after the procedure.

Manufacturer Narrative

The referenced in this report has not yet been returned to olympus for evaluation (although it is anticipated).The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.This event has been reported by the importer on mdr# 2951238 ¿ 2022- 00400.

Manufacturer Narrative

This report is being updated to provide investigation findings.Physical evaluation of the suspect device: olympus performed a visual inspection and observed; the distal end was free of any residue or foreign material.Two fingers were ran down the entire length of the insertion tube, no catching or other abnormalities found.In addition, the distal end, bending section cover, bending section cover glue and insertion tube portion was wiped down with a 4x4 cotton pad which did not catch or snag and no sharp objects are noted.During estimation the fiberscope was connected to a pressurized airline and submerged into a tub of water at which point it failed, due to the distal end cover leaking, at the seam.An olympus brush (bw-7b) was inserted into the biopsy port and down the channel without any restriction.During the functional inspection angulation is within the olympus standards.However, the image is off center.The device history record (dhr) for the complaint device has been reviewed.Since the subject device was refurbished product, olympus reviewed service request order information checklist detail.As a result, it was confirmed that the subject device has passed at any inspection without problem.The instructions for use (ifu) shipped with the device provides the user the following information related to the reported event: important information ¿ please read before use ¦warning and cautions: warning never insert or withdraw the insertion section abruptly or with excessive force.Patient injury, bleeding, and/or perforation may result.4.1 precautions: warning ¿ if significant resistance is felt during insertion due to an anatomical reason, do not insert or withdraw the endoscope with excessive force.Otherwise, ureter injury, bleeding, and/or perforation may occur.¿ never insert or withdraw the endoscope under any of the following conditions.Patient injury, bleeding, and/or perforation can result.-insertion or withdrawal with excessive force.Conclusion: the definitive cause of the reported events could not be established.As a result of investigation, we could not confirm the fact that supports occurrence of the suggested event due to abnormality in the device.According to the comment from the doctor shown below, ureteral spasm was raised as a cause that the device was unbale to be withdrawn.In addition, the doctor raised extensive manipulation of the device inside the ureter as a factor that caused the ureteral spasm.¿at the conclusion of the procedure, the physician attempted to remove the scope and was unable to because the ureter had begun to spasm due to the extensive manipulation.¿ ·abnormality, which could be a cause that the device was unable to be withdrawn was not confirmed.

• Brand Name: URETERO-RENO FIBERSCOPE
• Type of Device: FLEXIBLE FIBREOPTIC URETERORENOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14368142
• MDR Text Key: 294676263
• Report Number: 8010047-2022-08103
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04953170340833
• UDI-Public: 04953170340833
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/12/2022

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-P6R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/14/2022
• Initial Date FDA Received: 05/12/2022
• Supplement Dates Manufacturer Received: 07/14/2022
• Supplement Dates FDA Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: URETERAL STENT, LASER
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Male