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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION LOOP CUTTER

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OLYMPUS MEDICAL SYSTEMS CORPORATION LOOP CUTTER Back to Search Results
Model Number FS-5L-1
Device Problem Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/25/2014
Event Type  malfunction  
Event Description
During an esophageal achalasia's postoperative inspection, the doctor tried to remove a suture thread using the subject device since he judged the suture thread used at the time of the operation could cause passage disorder.The suture thread was closely fixed to the mucous membrane, and the subject device got entangled.The scope was removed from the patient body after cutting of a part of the handle using pliers.After that the scope was inserted again, and the suture thread was cut using the spare (b)(4) device.Bleeding occurred in this occasion.
 
Manufacturer Narrative
The subject device was returned to olympus for investigation.The investigation confirmed that a suture thread was caught between a loop hanger and cutter and the suture thread could not be detached from the subject device.The purpose of the subject device is cutting a loop.The cause of this event is a user's attempt of cutting a suture thread, which is different from the original purpose.It is supposed that the suture thread was thin and easy to be caught between the loop hanger and cutter.The device instruction manual has indicated that this device can't be removed from a patient body if this device is used for different purposes.This report is being submitted as a medical device report in an abundance of caution.
 
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Brand Name
LOOP CUTTER
Type of Device
LOOP CUTTER
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORPORATION
2951 ishikawa-cho
hachioji-shi, tokyo 192-8 507
JA  192-8507
Manufacturer Contact
hiroki moriyama
2951 ishikawa-cho
hachioji-shi, tokyo 192-8-507
JA   192-8507
26425177
MDR Report Key4456762
MDR Text Key5422275
Report Number8010047-2015-00040
Device Sequence Number1
Product Code HIN
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 12/25/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFS-5L-1
Device Lot NumberK8X23
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/14/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/25/2014
Initial Date FDA Received01/19/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/1998
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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