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

Model Number URF-V2

Device Problems Break (1069); Material Perforation (2205)

Patient Problem Laceration(s) (1946)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus medical systems corp.But was returned to olympus (b)(4) for investigation.(b)(4) found that the bending rubber of the subject was damaged and the subject device failed leak test.The bending tube was separated.There was restriction in the biopsy channel.The angulation function was not within the specification.The manufacturing record of the subject device was reviewed with no irregularity related to the phenomenon.The subject device was last serviced by olympus on may 3, 2016 to replace the insertion unit due to a detached bending section.The subject device was also serviced by the tbs, non-olympus repair company, on november 25, 2016.From the service record of the tbs, lens assembly was resealed, the insertion unit including optical light transmission, angulation system and the ccd was replaced, electrical connector was re-terminated, and control body was replaced.The exact cause of the event could not be concluded at this moment.If additional and significant information becomes available, this report will be supplemented.

Event Description

The subject device was used to retrieve kidney stones during a percutaneous nephrolithotomy.During the procedure, the user facility felt resistance to remove the subject device.Though the metal sheath ((b)(4)) concomitantly used with the subject device was removed from the patient¿s kidney along the subject device, the subject device could not be removed due to the resistance.The user facility noted that the subject device appeared kinked on x-ray image.Then the user facility enlarged the skin incision on the patient and removed the subject device.The user facility visually inspected the subject device, and noted damage in the bending section and an exposure of inner part from the bending rubber.A subsequent examination of the upper urinary tract with another ureteroscope showed no evidence of ureteric or renal pelvic injury and no evidence of remained device material.Inspection before use was reportedly conducted by odp (operating department practitioner) as per the instruction.The user facility noticed no issue with the subject device prior to use.The patient has recovered from the surgery.The patient had an extended stay due to a chest infection.

Manufacturer Narrative

This supplemental report is being submitted to provide the evaluation result.The subject device was returned to olympus medical systems corp.For evaluation.During the evaluation, it was found that there was damage in the bending tube at the proximal side.As there was a crack at the left side of the bending tube, it was presumed that forcible stress was loaded at the left side of the bending tube.After the bending rubber of the subject device was removed, it was found that there was a white deposit in the gap at the tip of the bending tube.The white deposit was analyzed and identified as a material containing (b)(4).Olympus does not use a material containing (b)(4)to the bending section of the subject device.It was also found that two cable supports at the second and third from the distal end were detached from the bending tube.As it was reported in the initial report, the subject device has been serviced by a third party and the insertion unit was replaced.The white deposit in the gap at the tip of the bending tube was not supplied by olympus but it may be added by the third party.The influence of third party repair on this event is unknown.Olympus does not allow non-olympus repair as instructed in the instruction manual of the subject device: olympus is not liable for any injury or damage that occurs as a result of repairs attempted by non-olympus personnel.

• 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: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo-to ; 8142642517
• MDR Report Key: 6367128
• MDR Text Key: 68593171
• Report Number: 8010047-2017-00217
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2429304-12/12/2016-041C
• Patient Sequence Number: 1
• Patient Outcome(s): Other