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 08/29/2017

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, (b)(4) found that there were broken image fibers, broken/cracked bending tube, and water leak at the bending section.The bending function did not satisfy the product specification.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 medical systems corp.(omsc) was informed that the bending section of the subject device damaged and metal parts was protruded from the bending rubber of the subject device in the early stage of a procedure.The procedure was completed without replacing the subject device.It was also reported that urology endoscopy equipment such as a rigid cystoscope or a rigid ureteroscope was concomitantly used with the subject device.There was no report of patient injury associated with this report.The patient is reportedly doing well.

• 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: 6903219
• MDR Text Key: 89540688
• Report Number: 8010047-2017-01397
• 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: Nurse
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 09/29/2017

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2017
• Initial Date FDA Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2013
• 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