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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA SMALL INTESTINAL VIDEOSCOPE SMALL INTESTINAL VIDEOSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. EVIS LUCERA SMALL INTESTINAL VIDEOSCOPE SMALL INTESTINAL VIDEOSCOPE Back to Search Results
Model Number SIF-Q260
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/21/2021
Event Type  malfunction  
Manufacturer Narrative
The subject device was not returned to omsc for evaluation but was returned to olympus (b)(4). (b)(4) checked the subject device and found that the followings. There was a transparent nylon fiber inside the instrument channel outlet. There was no leakage in the subject device. The instrument channel was damaged. A part of the damaged cleaning brush (about 1cm) was pushed out from the instrument channel during cleaning / brushing in the sink. There was no obvious clogging inside the instrument channel. Omsc reviewed the device history record (dhr) of the subject device and confirmed no irregularity. The exact cause of the reported phenomenon could not be conclusively determined. However, based upon the following information, there was the possibility that this phenomenon was attributed to the distal end of the brush remained inside the subject device due to the deterioration damage by the repeated brushing with the cleaning brush. Based upon the similar event, the brush remained inside the channel of the subject device due to the deterioration damage by the repeated reprocessing with the cleaning brush. There is the description in the instruction for use that, ¿the channel cleaning brush is a consumable. Repeated use may cause the brush head to become bent or kinked, which could cause it to come off during use. ¿ olympus stated the appropriate handling of sif-q260 and the counter measures against abnormalities in the instruction manual of sif-q260.
 
Event Description
Olympus medical systems corp. (omsc) was informed from the user that during a single balloon enteroscopy procedure, it was found that a forceps and a brush were caught inside the subject device, and like a thin metal fiber was come out and went into the patient from the subject device. The user completed the intended procedure with the subject device. There was no delay in the procedure. There was no report of patient injury associated with the event.
 
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Brand NameEVIS LUCERA SMALL INTESTINAL VIDEOSCOPE
Type of DeviceSMALL INTESTINAL 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 Key11996879
MDR Text Key271761680
Report Number8010047-2021-07519
Device Sequence Number1
Product Code FDA
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial
Report Date 06/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSIF-Q260
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/21/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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