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

Model Number URF-P6

Device Problems Break (1069); Fracture (1260); Material Deformation (2976)

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

Event Date 05/24/2017

Event Type  malfunction  

Manufacturer Narrative

The 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 investigation, okm found that there were a kink in the bending section of the subject device and a water leak in the bending rubber.When okm removed the bending rubber, breakage in the bending tube was found.The manufacturing record of the subject device was reviewed with no irregularity.If additional and significant information becomes available, this report will be supplemented.

Event Description

Olympus was informed that the subject device was used on a patient and snapped inside the patient.It was also reported when the surgeon tried to angulate the distal end, the subject device was broken.There was no fragment broken off, but a metal part of the bending section was exposed from the bending rubber.This phenomenon was reportedly occurred with the same model before.There was no patient injury associated with this event 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: 6659472
• MDR Text Key: 78252390
• Report Number: 8010047-2017-00765
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PK912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• 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
• Date Manufacturer Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2429304-12/12/2016-042C
• Patient Sequence Number: 1