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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-0330
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/22/2017
Event Type  Malfunction  
Manufacturer Narrative

The subject device was returned to olympus medical system corp. (omsc) for investigation. As a result of the investigation on (b)(6) 2017, it was confirmed that the cutting wire of the subject device was broken. The broken section of the cutting wire was melted and burned. The coating of the broken section was torn. Additionally, the coating on the cutting wire was missing about 5. 0 mm to the specification. As a measurement result of the outer diameter of the cutting wire, there was no abnormality. The device history record for the lot indicated no abnormality with the event-related items below. Length of the pfa wire. Appearance of the pfa wire. Operation of the cutting wire. The overall appearance this type of damage is most likely related to the operator¿s technique. Based on the past similar cases, omsc assumes that the damage of the coating 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 the device was activated the output, and it caused spark. Then, a part of the cutting wire became extremely hot, resulting in breakage. Omsc assumed that the missing of the coating occurred because the coating near the broken part of the cutting wire was subjected to a load during user handling, but the cause could not be conclusively determined. The instruction manual of the device has already 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. When inserting the instrument into the endoscope, be sure that the cutting wire is parallel to the tube. Otherwise, the metal part of the forceps elevator may contact the cutting wire and peel off the coating material. Do not activate output while tissue is in contact with the torn or damaged coated portion of the distal end. If output is activated while tissue is contacting the torn or damaged coated portion due to insertion into or withdrawal from an endoscope, leakage current, decreased output, and/or thermal injury could result.

 
Event Description

During an endoscopic sphincterotomy, the subject device was used. It was reported that the cutting wire of the subject device was broken. There was no patient injury reported. The subject device was returned to olympus medical system corp. (omsc) for investigation. As a result of the investigation on (b)(6) 2017, it was confirmed that the cutting wire of the subject device was broken. Additionally, the coating on the cutting wire was missing about 5. 0mm to the specification.

 
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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
426425177
MDR Report Key7145434
MDR Text Key95974492
Report Number8010047-2017-02091
Device Sequence Number1
Product Code KNS
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberPK950166
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 12/26/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/26/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberKD-V411M-0330
Device LOT Number72V
OTHER Device ID Number04953170380563
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/01/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/18/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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