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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VIDEOSCOPE "URF-V" URETERO-RENO VIDEOSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. VIDEOSCOPE "URF-V" URETERO-RENO VIDEOSCOPE Back to Search Results
Model Number URF-V
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The event date is (b)(6) 2021, when the adhesive was noted to be peeling on forceps cover. The reporter¿s contact information, occupation and health profession are unknown at this time. Further inspection of the returned device found bite marks on the insertion portion of the scope. The distal end cover was observed to be burnt. Moisture was noted in the scope¿s control unit and the switch box was corroded with short wires. The cause of the physical damage to the scope cannot be determined at this time. An investigation is ongoing to obtain additional information regarding the reported event. If additional information is received this report will be supplemented accordingly.
 
Event Description
The customer was reported a leak at distal end of the scope. There was no patient involvement report. The device was returned for evaluation and found the scope leaking and protruding metal from the bending section rubber. This report is being submitted to address the protruding metal observed during evaluation.
 
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Brand NameVIDEOSCOPE "URF-V"
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 Key12958342
MDR Text Key284178283
Report Number8010047-2021-15714
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K072957
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 02/22/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-V
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/09/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/02/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/11/2011
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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