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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 Problem Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/29/2021
Event Type  malfunction  
Event Description
It was reported by the customer, the bending section rubber was leaking due to a broken bending section on the uretero-reno videoscope. The issue was found during precleaning. The endoscope had been used normally. The wear on the bending section had occurred after the scope had been used only thirty-seven (37) times after the endoscope was purchased in 2019. The damaged scope was not used again with the leaking bending section rubber but was possibly with a damaged bending section. The user was not inconvenienced. No patient harm reported. During the evaluation of the device, it was noted the insertion tube/bending section cover was deformed. This report is to capture the reportable malfunction of the deformed insertion tube/bending section cover noted at estimation.
 
Manufacturer Narrative
The device was returned to an olympus service center for evaluation and the reported issue was confirmed. There was metal sticking out of the pinholes in the bending section cover (sticking out of a-braid or a-wire) on the insertion tube causing the air/water leakage. The investigation is ongoing. A supplemental report will be submitted upon completion of the investigation.
 
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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 Key12950584
MDR Text Key285623922
Report Number8010047-2021-15650
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K181451
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/06/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/07/2021
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 Manufacturer11/11/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/23/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/19/2019
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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