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

Model Number URF-P6

Device Problem Poor Quality Image (1408)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

This device referenced in this report has not been returned to olympus medical systems corp.For evaluation, but was returned to olympus (b)(4).During the evaluation, (b)(4) confirmed the image irregularity, broken image fibers, damaged objective lens, and residue on the objective lens.The manufacturing record of the subject device was reviewed with no irregularity.Considering the information from the user facility and the result of the evaluation, omsc concluded that the event possibly occurred due to improper handling of the laser.Olympus instruction manual warns that ¿do not irradiate the laser without viewing the tip of the laser probe and the aiming beam in the endoscopic image.¿.

Event Description

Olympus was informed that during unspecified therapeutic procedure with a laser, the endoscopic image of the subject device became bad when the objective lens was damaged and burned by the laser.The user replaced the subject device with an unspecified similar device and the procedure was completed.There was no patient injury reported.

• Brand Name: URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 7147027
• MDR Text Key: 96235451
• Report Number: 8010047-2017-02102
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: PK072957
• 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: 12/27/2017

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
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 12/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2015
• 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