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

Model Number URF-P5

Device Problems Break (1069); Fracture (1260); Material Fragmentation (1261); Melted (1385); Material Deformation (2976)

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

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus medical systems corp.For evaluation.If additional and significant information becomes available, this report will be supplemented.

Event Description

Olympus (b)(4) investigated the subject device and it was found that the distal cover was burned / melted and partially missing.It was also found that there was image irregularity with the subject device.There was no patient injury associated with this event reported.

Manufacturer Narrative

This supplemental report is being submitted as additional information has been obtained.The manufacturing record of the subject device was reviewed without irregularity related to this event.

Manufacturer Narrative

This supplemental report is submitting to correct "device product code".

• Brand Name: OES URETERO-RENO FIBERSCOPE
• Type of Device: URETERO-RENO FIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to ; 426425177
• MDR Report Key: 6756219
• MDR Text Key: 82126725
• Report Number: 8010047-2017-01120
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK912120
• 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,Followup,Followup
• Report Date: 02/22/2019

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-P5
• Other Device ID Number: 04042761066693
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/04/2017
• Initial Date FDA Received: 08/01/2017
• Supplement Dates Manufacturer Received: 08/04/2017; 02/13/2019
• Supplement Dates FDA Received: 08/28/2017; 02/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1