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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE 3-LUMEN SPHINCTEROTOME V

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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE 3-LUMEN SPHINCTEROTOME V Back to Search Results
Model Number KD-V411M-0720
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/14/2016
Event Type  malfunction  
Manufacturer Narrative
The subject product was returned to omsc for investigation.The investigation confirmed that the coating on the cutting wire was torn and the cutting wire was broken.The broken section was melted and burned.Approximately cutting wire was missing for 7.0 mm from the broken point.There were no other abnormalities related to the breakage in the subject device.As the checking of the manufacturing record of the same lot, nothing abnormal was detected.The length of the pfa wire, the appearance of the pfa wire, the movement of the cutting wire, the general appearance.This type of damage is most likely related to the operator's technique.As the results of the investigation, omsc assumes that the damage of the coating and cutting wire occurred due to contacting with the metal part of the forceps elevator of the endoscope.The exposed cutting wire from the damaged coating contacted or came close to the metal part of the forceps elevator while activating the output, which caused spark and a part of the cutting wire became extremely hot, resulting in breakage.The coating broke off and came off from the cutting wire because of the user handling after the cutting wire was broken.
 
Event Description
Olympus medical systems corp (omsc) was informed that during endoscopic sphincterotomy (est), knife wire was broken immediately after energization.The doctor exchanged the subject device for another device and completed the procedure.There was no patient injury reported.The subject product was returned to omsc for investigation on oct.21, 2016.The investigation confirmed that the coating on the cutting wire was torn and the cutting wire was broken.The broken section was melted and burned.Approximately coating was missing for 7.0 mm from the broken point.
 
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Brand Name
SINGLE USE 3-LUMEN SPHINCTEROTOME V
Type of Device
SPHINCTEROTOME
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951
ishikawa-cho
hachioji-shi, tokyo 192-8 507
JA  192-8507
Manufacturer Contact
kunimori yamaguchi
2951
ishikawa-cho
hachioji-shi, tokyo 192-8-507
JA   192-8507
42 6425117
MDR Report Key6062737
MDR Text Key58611071
Report Number8010047-2016-01412
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K950166
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other
Type of Report Initial
Report Date 10/28/2016
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 Physician
Device Model NumberKD-V411M-0720
Device Lot NumberK6420
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/20/2016
Initial Date Manufacturer Received 10/21/2016
Initial Date FDA Received10/27/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/20/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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