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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-V2
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The subject device was returned to sorc but has not been returned to omsc. Sorc checked the subject device for evaluation. It was confirmed that the metal part of the bending section of the subject device was punctured and exposed from its bending rubber. It was found the damages of the bending rubber and the metal part. Omsc reviewed the manufacture history (dhr) of the subject device and confirmed no irregularity. The exact cause of the reported phenomenon could not be conclusively determined. However, based upon the information from sorc omsc surmised that the reported phenomenon was attributed to the external factor such as contact to sharp instrument. If additional information is received, this report will be supplemented.
 
Event Description
Olympus medical systems corp. (omsc) was informed during the incoming inspection for repair at olympus service operation repair center (sorc), that it was found the metal part of the bending section of the subject device was punctured and exposed from its bending rubber. The subject device had been returned from the user because the subject device had the pin hole at the distal end. The occurrence date of the event is unknown. There was no report of patient injury associated with the event.
 
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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 Key12566396
MDR Text Key275144483
Report Number8010047-2021-12592
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K172246
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 10/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberURF-V2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/06/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/17/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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