MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO VIDEOSCOPE

Model Number URF-V2

Device Problem Entrapment of Device (1212)

Patient Problem Injury (2348)

Event Date 07/31/2018

Event Type  Injury  

Manufacturer Narrative

The scope has been sequestered at the user facility and is only available for an onsite evaluation at the facility.The cause of the reported event cannot be determined at this time.Olympus will continue to investigate this matter.As part of our investigation, an olympus endoscopy support specialist and engineer have been scheduled to visit the user facility on (b)(6) 2018 to perform an onsite evaluation of the referenced scope.If additional information becomes available this report will be supplemented accordingly.

Event Description

Olympus was informed that during a therapeutic ureterscopy procedure, upon visualization and after pass of the wire, the distal tip of the scope became stuck in the patient¿s renal pelvis.It was reported that there was no audible noise noted prior to the scope locking up.The doctor utilized a bolt cutter to remove the scope in three pieces.The patient sustained extreme swelling, prolonged anesthesia and mild trauma.The patient was hospitalized three days and then discharged.The intended procedure was aborted.The patient¿s procedure has been rescheduled for (b)(6) 2018.Additionally, the user facility reported that the scope¿s pre-inspection was performed prior to the procedure by the doctor with no anomalies found.

Manufacturer Narrative

The oem performed a review of the device history record (dhr) and found no anomalies during the assembly of the subject device and serial number.In addition, the oem reviewed the evaluation findings and complaint images provided from the olympus scope engineers that were taken during the onsite evaluation at the user facility.The oem determined that the cause of the event could not be reproduced or determined due to the subject device not being returned.This event will be logged and the oem will continue to monitor this phenomenon.

Manufacturer Narrative

This supplemental report is being submitted to report the device evaluation results.As part of our investigation, on september 7, 2018 two olympus¿ engineers visited the customer¿s site to perform an onsite evaluation of the urf-v2 scope.The engineers used a rectangular table to set-up the evaluation area for the urf-v2.A visual inspection was performed on the subject scope and found it enclosed in a plastic bag.The scope was removed from the bag and noted to be in three pieces: body control unit with light guide tube and video connector, a partial insertion tube with evidence of a bolt cutter cut on the insertion tube, and a partial bending section with distal end intact.The engineers inspected the scope¿s angulation lock and noted no abnormalities with its function.While inspecting the scope¿s bending section and internal components the engineers noted two missing cable supporters from the bending section: one from the up angulation cable and one from the down angulation cable.The bending section cover was removed for further inspection and it was noted the two cable supporters on the top side of the bending section were slightly lifted up.The bending section was broken into two separate sections with sharp edges on both sections.The up angulation wire and down angulation were noted to be crossed threaded in the same damaged hole and protruding into the bending section.The engineers were able to angulate the scope in a downward direction by manipulating the down angulation wire.The scope could not be angulated in the opposite direction with the up angulation wire.A kink was noted in the up angulation wire near the broken bending section area.The evaluation findings and scope images will be sent the oem for further investigation.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information received from the user facility¿s physician.Please the updates in sections: pma/510k, if follow-up, what type.Additional information received states that the doctor was approaching the lower pole, inferior calyx of the patient¿s kidney when the scope allegedly malfunctioned.The scope was locked in the downward direction at this time and the wire was unable to pass beyond the bend.The doctor reported that the patient¿s anatomy had a dramatic angle to the lower pole.This patient also had a stent placed prior to the procedure that remained in place for one week.The procedure was performed with x-ray and the doctor reported that there were no useful images.The urf-v2 insertion tube was not looped; however, was angulated into the patient¿s lower pole.A sheath had been placed in the patient¿s proximal ureter and was approximately 6cm away from the distal end.The doctor then attempted to pull the scope into the sheath and pass a basket when it was noted that the scope would not straighten.It is unknown if the scope¿s distal end could move freely prior to the procedure.Additionally, it was reported that the scope had been used approximately 10 times prior to this event.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 7795712
• MDR Text Key: 117567284
• Report Number: 2951238-2018-00472
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• PMA/PMN Number: K072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/03/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-V2
• Device Catalogue Number: URF-V2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/31/2018
• Initial Date FDA Received: 08/17/2018
• Supplement Dates Manufacturer Received: 09/07/2018; 10/02/2018; 12/18/2018
• Supplement Dates FDA Received: 09/28/2018; 10/18/2018; 01/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 39 YR
• Patient Weight: 94