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

Model Number OLYMPUS URF TYPE V

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2016

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to (b)(4) factory for evaluation.When the subject device was connected to a video system center at (b)(4) factory, the reported phenomenon was not reproduced.As a result of confirmation of the channel inside of the subject device, some pinholes were found at the place of around 40mm from the distal end and air leakage occurred from the pinholes.From the above, it is considered that this phenomenon might occur because moisture and water were invaded from the pinholes in the channel and the internal circuit of ccd unit temporarily short-circuited.It is considered that the short of the internal circuit of the ccd unit was caused by the insufficient maintenance of the subject device by the user facility, which had continued using such device with air leakage.

Event Description

Olympus medical systems corp(omsc) was informed that the endoscopic image disappeared at the end of flexible transurethral lithotomy with the subject device.The procedure was completed with the use of another spare device.There was no patient injury reported.

• Brand Name: OLYMPUS
• Type of Device: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951 ishikawa-cho; hachiouji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: nishina susumu ; 2951 ishikawa-cho,; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 6425177
• MDR Report Key: 6147119
• MDR Text Key: 61504888
• Report Number: 8010047-2016-01517
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/06/2016

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: OLYMPUS URF TYPE V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2016
• Initial Date FDA Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• 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