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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. FIBERSCOPE "URF-P5", SET E URETERO-RENO FIBERSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. FIBERSCOPE "URF-P5", SET E URETERO-RENO FIBERSCOPE Back to Search Results
Model Number URF-P5
Device Problem Peeled/Delaminated (1454)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/15/2021
Event Type  malfunction  
Event Description
A user facility reported that the flexible scope sheath is torn and was peeling at the tip. The customer mentioned that the device was hit by a laser fiber. The event occurred during preparation for use, prior to an unknown diagnostic procedure. During a standard service inspection of the customer returned device, insertion tube peeling was noted. This report is to capture the reportable malfunction found at inspection. There was no patient involvement, no harm or user injury reported due to the event.
 
Manufacturer Narrative
The device was returned for investigation. Upon evaluation of the device, insertion tube peeling, bending section cover crack, and image with 30 plus lg breakage were observed. The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time, however, if additional information becomes available, this report will be supplemented accordingly.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation. A review of the device history record found no deviations that could have caused or contributed to the reported issue. It has been over 12 years since the subject device was manufactured. Based on the results of the legal manufacturer's investigation, the root cause of the insertion tube peeling could not be identified. Per the instructions for use: while holding the insertion tube gently with one hand, carefully run your fingertips of the other hand over the entire length of the insertion tube in both directions. Confirm that there is no object stopping the hand or protruding objects or other irregularities. Olympus will continue to monitor field performance for this device.
 
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Brand NameFIBERSCOPE "URF-P5", SET E
Type of DeviceURETERO-RENO FIBERSCOPE
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 Key13220445
MDR Text Key286432325
Report Number8010047-2022-01203
Device Sequence Number1
Product Code FGB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K912120
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 02/04/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberURF-P5
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/20/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/16/2009
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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