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

Model Number URF-V

Device Problems Leak/Splash (1354); Mechanical Problem (1384); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2015

Event Type  malfunction  

Event Description

Olympus medical systems corp.(omsc) was informed that when the tip of the subject device was in the urethra of the patient during the pnl procedure, the user could not perform angulation control and aborted the procedure.Furthermore, the user facility found the image was noisy and there was in a pinhole in the tip of the subject device.The user facility gave an account to the patient after the patient came to his senses.The treatment would be performed after one month.There was no patient harm reported.The user facility provided a comment to olympus that the pinhole might be made by a mistake of the laser activation timing, during an operation that was performed in past times.

Manufacturer Narrative

The subject device was returned to omsc for evaluation.Based upon the evaluation of the subject device by omsc, the angulation could not perform in the up direction and noisy image in the horizontal direction occurred infrequently.Furthermore, the leakage test was performed and the subject device failed seriously due to pinholes in the opening of the instrument channel and the bending cover.Also there was a pinhole from the instrument channel to the outside of the bending cover at about 20cm from the tip of the subject device in the left side.Based upon the findings that there were no scratches around the pinhole and the user's comment, omsc concluded that user facility activated the laser in improper timing such as when the tip of the laser was still in the instruction channel.This report is being submitted as a medical device report in an abundance of caution.The manufacturing history was reviewed, but with no irregularities related to this problem noted.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: susumu nishina ; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 26425177
• MDR Report Key: 4963706
• MDR Text Key: 6191247
• Report Number: 8010047-2015-00615
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URF-V
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/09/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2015
• Initial Date FDA Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1