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

Model Number URF-V2

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems Pain (1994); Intraoperative Pain (2662)

Event Date 11/01/2017

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus medical systems corp.For evaluation, but was returned to olympus (b)(4) in (b)(6) during the investigation by (b)(4), it was confirmed that the bending tube breakage, water leak at the bending section, and the angulation being out of standard.The manufacturing record of the subject device was reviewed without irregularity related to this event.The subject device was last returned to olympus for repair on (b)(6) 2017.The service record shows the subject device had major repair to rectify a damaged bending section.The subject device had subsequently been used three times.According to the user, the subject device was inspected before and after reprocessing, and prior to insertion to a patient.There was no record of the device malfunction in the inspection.The exact cause of the event could not be conclusively determined at this moment.If additional and significant information becomes available, this report will be supplemented.

Event Description

Olympus was informed that the patient had a torturous in the ureter at proximal side, during the insertion of the subject device.The user felt slight difficulty in insertion than usual.Ten minutes after starting renal pelvis observation, the user felt anomaly in the subject device and so an x ray image was checked.The x-ray image showed the breakage in the bending section.The user inserted a guide wire (manufactured by boston scientific, brand name: sensor) into the channel to straighten the subject device and then, withdrew the subject device back to the access sheath.The subject device and the access sheath were carefully removed.A ureteric stent was placed to the patient and the procedure was aborted.The patient had a prolonged admission at least an extra 48 hours than it was expected, received a course of antibiotics, and then was released.

Manufacturer Narrative

The device referenced in this report has been returned to olympus medical systems corp.(omsc) for evaluation.During the evaluation by omsc, it was confirmed that all the cable support fixed on the bending tube was detached.It was also confirmed that there were cracks in the bending tube from the down side towards the left and right side.From the direction of the cracks, the bending tube might be broken by stress from up or down direction when the bending section of the subject device was angulated and the subject device was pushed into the patient.From our causal investigation result, it was confirmed that under the condition where the distal end of the scope comes in contact with an inner wall of a kidney, if the scope is repeatedly further pushed, the bending tube breakage occurs.Therefore, the bending tube breakage in this report is considered to have occurred in the above mechanism.The instruction manual contains several statements in an effort to prevent bending section damage.¿do not insert the insertion tube with excessive force into the ureter or calix.The bending section may be damaged.¿ ¿do not operate the angulation control lever with excessive force in a narrow space to the opposite direction from the bending direction while the distal end of the endoscope is not moved.The bending section may be damaged.Check the tip position of the endoscope and the shape of the bending section using fluoroscopy, etc.Do not insert the insertion tube with excessive force and twist.¿.

• 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
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to ; 426425177
• MDR Report Key: 7058296
• MDR Text Key: 92900349
• Report Number: 8010047-2017-01855
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/14/2018

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-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2017
• Initial Date FDA Received: 11/26/2017
• Supplement Dates Manufacturer Received: 02/16/2018
• Supplement Dates FDA Received: 03/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2015
• 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
• Patient Outcome(s): Other