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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-P7R
Device Problems No Display/Image (1183); Defective Device (2588)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Device was received and evaluated.Evaluation determined that the device failed a leak test due to leak found from the bending cover of the unit.Stain was observed on the image.Device was placed for repair.Customer received a replacement unit.If additional information becomes available this report will be supplemented accordingly.
 
Event Description
It was reported that the scope device is broken.No further details provided regarding the event.No patient harm or injury reported.No user injury reported.
 
Manufacturer Narrative
This supplemental report is being submitted to inform that upon further review this is not a reportable malfunction.Per the legal manufacturer there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.
 
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Brand Name
URETERO-RENO FIBERSCOPE
Type of Device
URETERO-RENO FIBERSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
MDR Report Key10948237
MDR Text Key226706417
Report Number8010047-2020-09844
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
PMA/PMN Number
K181451
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 01/18/2021
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 NumberURF-P7R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/06/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/06/2020
Initial Date FDA Received12/04/2020
Supplement Dates Manufacturer Received01/17/2021
Supplement Dates FDA Received01/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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