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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO FIBERSCOPE Back to Search Results
Model Number URF-P6R
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The scope was returned to olympus for service. Besides the broken ribs, the device estimation found more than 20 broken fibers in the image. The scope also could not be angulated due to the broken ribs. A review of the service history of the scope found five repairs in the past two years, all involving mechanical damage or leaks in the scope. To mitigate against scope damage and patient injury, both the scope operation manual and instructions for safe use documents contains several warning statements regarding inspection and operation. It was reported that the user facility did receive the instructions for safe use document. The instructions for safe use states, ¿visually inspect the bending section for no metallic parts protruding from the bending section¿ prior to the procedure, and includes photos for reference. The operation manual likewise states that prior to scope use, ¿inspect the external surface of the entire insertion section, including the bending section and the distal end for dents, bulges, swelling, scratches, peeling of coating, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities. ¿ and ¿gently hold the vicinity of the distal end and at the point 10 cm from the distal end. Push and pull gently to confirm that the junction between the bending section and the insertion tube is not loose and that no irregularities are observed on the bending section. ¿ the operation manual also recommends ¿be sure to prepare another endoscope to avoid interruption of the examination due to equipment failure or malfunction. ¿.
 
Event Description
Olympus was informed that following an unspecified procedure, during post-procedure reprocessing, the scope was found to have a tear at the distal end, with sharp edges sticking up. There was no reported patient injury. It was reported that the scope was inspected prior to use with no anomalies found.
 
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Brand NameURETERO-RENO FIBERSCOPE
Type of DeviceURETERO-RENO FIBERSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to
Manufacturer Contact
connie tubera
2400 ringwood avenue
san jose, CA 95131
4089355124
MDR Report Key8044714
MDR Text Key128562611
Report Number2951238-2018-00671
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K912120
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-P6R
Device Catalogue NumberURF-P6R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/18/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/13/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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