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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 Device Reprocessing Problem (1091)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The investigation is ongoing; therefore, the root cause of the reported issue/malfunction cannot be determined at this time. However, if additional information becomes available a follow up medical device report will be supplemented accordingly.
 
Event Description
During a demonstration, the olympus field service engineer discovered cyf and urf type endoscopes were cleaned with a broken endoscope washer-disinfector machine as a broken pull rod for the upper basket the machine was observed. The customer mainly cleans the endoscopes without internal radio-frequency identification (rfid) and the machine did not report any error for the broken pull rod. Thus, channels of the endoscope may not have been cleaned properly without the machine indicating this. No death, injury or infection has been reported. This is for report 2 of 2.
 
Manufacturer Narrative
This supplemental report was submitted to provide additional information regarding the machine and the scopes. It was further reported that the washer machine has been repaired. Also, the urf and cyf scopes been cleaned after machine was repaired. Customer has not reported patient infection or cross-contamination.
 
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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
MDR Report Key12698303
MDR Text Key282122625
Report Number8010047-2021-13654
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
PMA/PMN Number
K172246
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-V2
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/28/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/26/2021 Patient Sequence Number: 1
Treatment
ENDOSCOPE WASHER WD00104A, SN (B)(4)
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