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

Model Number URF-V2

Device Problems Break (1069); Corroded (1131); Degraded (1153); Difficult to Remove (1528)

Patient Problem Injury (2348)

Event Date 07/05/2017

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has been returned to olympus medical systems corp.For evaluation.During the evaluation, it was confirmed that there was malfunction in the angulation mechanism and, rupture and turnover of the bending rubber.The followings were also confirmed: -corrosion inside the bending section -damage in the bending tube -fixation and corrosion of the angulation wire in the insertion section and grip section -corrosion inside the grip section -corrosion inside the venting connector -corrosion at the instrument port.Corrosion was found in the subject device, but there was no irregularity in the instrument channel such as a pinhole.The manufacturing record of the device was reviewed with no irregularity relating to the phenomenon.The exact cause of the event could not be concluded at this moment however, it might be a possible cause that the bending rubber was cut by calculus and the bending rubber was turned up when the subject device was tried to be removed from the patient, then the subject device got stuck.

Event Description

Olympus was informed that the subject device got incarcerated and stuck in the patient ureter during a f-tul (transurethral ureterolithotomy) procedure.The subject device was inserted into kidney for a ureteroscopic examination without a laser or a therapeutic device inserted into the instrument channel of the subject device.After that, the user felt the subject device to be caught when the user was trying to withdraw the subject device, and the user could not remove the subject device.Therefore, the user performed an open surgery to cut the ureter so that the subject device became movable, and removed the subject device.During the surgery, the user retrieved a part of the bending rubber that fell off during the procedure.The procedure was completed after the user inosculated the ureter of the patient.The user commented that the subject device seemed to get stuck by surrounded with fine sand-shaped calculus.

• 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 192-8 507; JA 192-8507
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 6770027
• MDR Text Key: 81903777
• Report Number: 8010047-2017-01161
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/07/2017

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2017
• Initial Date Manufacturer Received: 07/10/2017
• Initial Date FDA Received: 08/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2429304-12/12/2016-041C
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention