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

Model Number URF-V

Device Problems False Device Output (1226); Leak/Splash (1354); Improper Device Output (2953)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2015

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus for evaluation.The reported phenomenon did not reproduce itself, but the image noise was observed.In addition, a meandering tube, irregular bending shape, and fixation in the angle lever were noted.The device failed the leak test at the instrument channel.There was a trace of burn and melting around the opening of the instrument channel, and the channel was curled up.The subject device was disassembled and evaluated, and multiple sites inside the device were found rusted and corroded.Based on the evaluation result above, it is considered that water invaded inside the device to cause electrical malfunction such as short circuit, in the imaging unit and so on, and it resulted in the reported phenomenon.It is considered that since the user erroneously irradiated a laser while the outlet was retracted inside the channel, the instrument channel was perforated, and water invaded from the perforation.There was no abnormality possibly associated with the reported phenomenon in the manufacturing records of the subject device.

Event Description

After removing majority of ureteral calculus using unknown rigid scope, the user inserted the subject device to check if there was any stone left in the renal pelvis.Following the placement of the catheter to complete the intended procedure, the image was lost before the subject device was removed from the patient.There was no patient injury reported.

• Brand Name: URETERO-RENO VIDEOSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 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 ; 6425177
• MDR Report Key: 5277115
• MDR Text Key: 33038567
• Report Number: 8010047-2015-01280
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• PMA/PMN Number: K#:K072957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial
• Report Date: 11/11/2015

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: Other
• Device Model Number: URF-V
• Device Catalogue Number: URF-V
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2015
• Initial Date Manufacturer Received: 11/11/2015
• Initial Date FDA Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2011
• 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