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

Model Number URF-P6

Device Problems Misfocusing (1401); Poor Quality Image (1408); Optical Problem (3001)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2014

Event Type  malfunction  

Event Description

Olympus medical systems corp.(omsc) was informed that tul (transurethral ureterolithotripsy) procedure was started and the image abruptly misted after about 30 to 60 minutes from starting.The nurse of the facility informed tha the image might get poor when the user oscillated laser.The user changed the urf-p6 to other device and the defect of poor image resolved.So the user could complete the procedure.There was no patient harm reported.

Manufacturer Narrative

The subject device was returned to omsc for evaluation.The evaluation didn't confirm the user facility's report of mist.The objective lens sinks slightly in the lens frames, and the air leakage occurs at this point.As a result of the evaluation, omsc concluded that the adhesives of the lens flaked for a certain reason and the objective lens sunk.Therefore, the focus gap took place.

• Brand Name: URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 26425177
• MDR Report Key: 4008994
• MDR Text Key: 4779277
• Report Number: 8010047-2014-00370
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/12/2014

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-P6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2014
• Initial Date FDA Received: 07/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1