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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 Break (1069)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The scope was returned to the service center for evaluation. The scope failed the leak test due to bending section cover glue. The bending section rubber was found to have a hole/cut. There was no pass between the forceps and brush passage. The bending section was found broken with sharp metal sticking out. The scope¿s angulation was checked and found to be very low. All switches were found functional and the image was normal. The instruction manual for the urf-v2r provided statements to mitigate damage to the scope¿s bending section. Do not bend, hit, pull, or twist the insertion section, bending section, control section, universal cord, video cable, video connector, and light guide connector. The endoscope may be damaged, and water leakage and/or breakage of internal parts like the image sensor cable can result. 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. Never perform angulation control forcibly or abruptly. Never forcefully pull, twist, or rotate the angulated bending section. Patient injury, bleeding, and/or perforation may result. It may also become impossible to straighten the bending section during an examination. Do not twist or bend the bending section with your hands. Equipment damage may result. Do not squeeze the bending section forcefully. The covering of the bending section may stretch or break and cause water leakage.
 
Event Description
The service center was informed that during reprocessing, the scope was noted to be damaged. There was no report of patient involvement.
 
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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 192-8 507
JA 192-8507
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key10932050
MDR Text Key219163610
Report Number8010047-2020-09683
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172246
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-V2R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/13/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/07/2017
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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