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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 03/28/2014
Event Type  malfunction  
Event Description
Olympus medical systems corp (omsc) was informed that the doctor attempted to place an esophageal stent manufactured by (b)(4) to the patient and cut its band using the subject device.Then the band was stuck in the cutter and the doctor could not temporarily withdraw the device from the patient.The doctor burned off the band with a laser and withdrew the device from the patient.The procedure was completed with another device.There was no report of patient injury regarding this report.
 
Manufacturer Narrative
The subject device was returned to omsc for investigation, the investigation confirmed that the band was stuck in the cutter part.When removing it from cutter part, the cutter opened and closed smoothly.The cutter was not deformed and as the result of checking the manufacturing record of the same lot, nothing abnormal was detected.Thus, omsc considers that cutting the band of the stent caused this event.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 Key3931343
MDR Text Key20326155
Report Number8010047-2014-00169
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 Nurse
Type of Report Initial
Report Date 03/28/2014
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 NumberK2Y30-0154
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/07/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/28/2014
Initial Date FDA Received04/04/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2002
Is the Device Single Use? No
Patient Sequence Number1
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