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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Burn(s) (1757)
Event Date 11/16/2017
Event Type  Injury  
Manufacturer Narrative
The subject device was returned to olympus medical system corp. (omsc) for investigation. As a result of the investigation, omsc confirmed that the device could apply current normally. As a measurement result of the resistance value between the knife wire and the plug of the operation part, there was no anomaly. The coating on the cutting wire was torn. The device history record for the lot indicated no abnormality with the event-related items below. Appearance of the pfa coating part on the cutting wire. Dc resistance value of the cutting wire. This type of event is most likely related to the operator¿s technique. Based on the past similar cases, omsc assumes that this event occurred because the coating on the cutting wire was torn. The coating on the cutting wire was torn and the cutting wire was exposed. The exposed cutting wire contacted the non-target tissue during activation. As a result, burn occurred and the papilla could not be incised with the subject device due to leakage of electric current to the non-target tissue. Omsc assumes that the damage of the coating occurred due to contacting with the metal part of the forceps elevator of the endoscope. The instruction manual of the device has already warned as follows; 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. If you feel the cutting is blunt, withdraw the device from the scope to examine if there is any peel off and tear at the coating portion. 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.
 
Event Description
During an endoscopic sphincterotomy, the subject device was used. It was reported that the papilla could not be incised with the subject device. The peripheral equipment was replaced with another equipment, and the procedure was completed with the subject device. The physician noticed that the area around the papilla was a condition like burn when retrieving the endoscope. No additional treatment was required. There was no further patient injury reported.
 
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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 Key7107165
MDR Text Key94473998
Report Number8010047-2017-01968
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 12/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberKD-V411M-0725
Device Lot Number77K
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/25/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/11/2017 Patient Sequence Number: 1
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