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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-V3
Device Problems Break (1069); Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The service technician found bending section breakage which showed a significant amount of metal exposure and also a perforation of the bending section cover which attributed to the customer reported "distal end leak". Additionally, the scope was leaking out from the instrument channel at the distal end; no fluid invasion. The video connector paddle was cracked. The scope was sold in august 2019 and was last serviced via repair in december 2019 for a locked angulation issue. The investigation is ongoing; therefore, the root cause of the reported issue cannot be determined at this time. However, if additional information becomes available a follow up medical device report will be supplemented accordingly.
 
Event Description
The regional repair center (ofr) was informed the customer uretero-reno videoscope was returned for service for a reported "distal end leaky" observed during a laparoscopy cholecystectomy procedure. The intended procedure was completed. No patient injury or harm was reported. However, during inspection and testing, the service technician found bending section breakage which showed a significant amount of metal exposure and also a perforation of the bending section cover.
 
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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 Key13123450
MDR Text Key285057301
Report Number8010047-2021-17012
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K181451
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/08/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-V3
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/16/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/16/2019
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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