MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VIDEOSCOPE "URF-V"; URETERO-RENO VIDEOSCOPE

Model Number URF-V

Device Problem No Display/Image (1183)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to olympus medical systems corp.(omsc) but was returned to olympus (b)(4) for evaluation.During the evaluation by (b)(4), the malfunction of the endoscopic image of the subject device was not duplicated.In addition, the evaluation confirmed signs of water immersion on circuit board within the video connector.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.Considering the evaluation result, it was surmised that the reported event occurred by damage of the electrical image unit (ccd) due to the water immersion.

Event Description

Olympus medical systems corp.(omsc) was informed that before a therapeutic procedure using the subject device, the endoscopic image of the subject device was not displayed in combination with an olympus video system center (otv-s190).At that time, the patient was given a local anesthesia.The user facility changed the subject device as a result and completed the procedure.However, the procedure time was prolonged.There was no report of patient injury associated with the event.

• Brand Name: VIDEOSCOPE "URF-V"
• 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: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 8521941
• MDR Text Key: 142630220
• Report Number: 8010047-2019-01712
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/17/2019

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: No Information
• Device Model Number: URF-V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/20/2019
• Initial Date FDA Received: 04/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1