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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. URETERO-RENO VIDEOSCOPE Back to Search Results
Model Number URF-V2R
Device Problem Detachment Of Device Component (1104)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
This supplemental report is being submitted to make a correction on the procode from nwb to fgb.
 
Manufacturer Narrative
The scope was returned to olympus for evaluation. The evaluation confirmed the reported device damage. The cable support on the bending section skeleton area was protruding out of the bending section cover. The bending section cover was removed and found the cable support from the bending section skeleton broken and lifting. The scope was serviced and returned to the user facility. This type of bending section damage is attributed to excessive force. The instruction manual for use states, "do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, video connector, or light guide connector. Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, video connector, or light guide connector with excessive force. The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations. It could also cause parts of the endoscope to fall off inside the patient. ¿.
 
Event Description
Olympus was informed that during preparation for use, it was noted that the scope¿s bending section rubber was coming off. There was no patient involvement with the reported device. The intended unspecified procedure was completed using a different scope.
 
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Brand NameURETERO-RENO VIDEOSCOPE
Type of DeviceURETERO-RENO VIDEOSCOPE
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
408935-512
MDR Report Key6337470
MDR Text Key191912230
Report Number2951238-2017-00084
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK072957
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 03/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-V2R
Device Catalogue NumberURF-V2R
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/20/2019
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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