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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 SINGLE USE 2-LUMEN SPHINCTEROTOME

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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE 3-LUMEN SPHINCTEROTOME V SINGLE USE 2-LUMEN SPHINCTEROTOME Back to Search Results
Model Number KD-V411M-0725
Device Problem Break (1069)
Patient Problem Burn(s) (1757)
Event Date 03/13/2017
Event Type  Injury  
Manufacturer Narrative
The subject product was returned to omsc for investigation. The investigation confirmed that the cutting wire was broken. The broken section was melted and burned. As a measurement result of the outer diameter of the knife wire, there was no abnormality. The device history record for the lot indicated no anomaly with the event-related items below. Dc resistance value of the knife wire. Operation of the knife wire. 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 coating of the cutting wire was likely caught and tore by the forceps elevator of the endoscope. The exposed cutting wire contacted or came close to the metal part of the forceps elevator while activating the output, and it caused spark and a part of the cutting wire became extremely hot, resulting in breakage. It is considered that when the knife wire was broken, the knife wire, which was heated, contacted to the papilla, causing the burn. The device instruction manual has warned as follows; since the cutting wire is very thin, it may break off in the following cases: the distance between the papilla of vater and the wire is very short, the output is too high or activated while the wire touches metal parts of the endoscope, or the wire is tightened too strong. When the wire breaks off, its proximal end will be retracted toward the endoscope if the slider is pulled. If the slider is pushed, the wire will be pushed out toward the papilla or move sideways. If the wire breaks off, stop the output immediately and pull the slider completely to retract the broken wire into the tube. Then withdraw the instrument from the papilla. Otherwise, patient injury,such as perforations, bleeding, or lacerations within the biliary duct and/or damage of the endoscope could result.
 
Event Description
Olympus medical systems corp (omsc) was informed that during ercp, the knife wire was broken after activation. The broken knife wire came in contact with the papilla of the 11 o'clock direction and burn occurred at the contact area. There was no bleeding at the burn site and no additional treatment was done. The procedure was completed with a spare device of the same model.
 
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Brand NameSINGLE USE 3-LUMEN SPHINCTEROTOME V
Type of DeviceSINGLE USE 2-LUMEN SPHINCTEROTOME
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA 192-8507
Manufacturer Contact
katsuaki morita
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
8142642517
MDR Report Key6480003
MDR Text Key72355357
Report Number8010047-2017-00422
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
PK950166
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberKD-V411M-0725
Device Lot NumberK7209
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/22/2017
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/16/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/09/2017
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/11/2017 Patient Sequence Number: 1
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