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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-0720
Device Problem Device Handling Problem (3265)
Patient Problem Burn(s) (1757)
Event Date 04/11/2017
Event Type  Injury  
Manufacturer Narrative
The subject device has not been returned to olympus medical system corp. (omsc) for evaluation. The exact cause of the reported phenomenon could not be conclusively determined. The lot number of the subject device is unknown. As a result of checking the manufacturing record of the past one-year from the incident date, nothing abnormal was found. Dc resistance value of the knife wire. Operation of the knife wire. It is surmised that the mucosal burn was caused by the following mechanism; the tip of the tube was not projected from the endoscope until the rear end of the knife wire was in the field of view. The knife wire was in contact with the forceps elevator of the endoscope. The electric leak to the elevator forceps occurred by the activation with the situation of the above (2), caused noise on the monitor. Mucosa burned because it was in contact with the heated forceps elevator of the endoscope due to electric leakage. 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. Be sure that the rear end of the cutting wire is extended from the distal end of the endoscope. Insufficient output or unintended tissue injury may occur in case the cutting wire contacts the forceps elevator.
 
Event Description
During an endoscopic sphincterotomy, the subject device was used. Noise occurred on the monitor during the procedure. It was reported that the duodenal mucosa near the papilla was burned. The physician continued the procedure without additional treatment. The procedure was completed with the subject device. There was no other 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 Key6525055
MDR Text Key73780338
Report Number8010047-2017-00515
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 Received04/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberKD-V411M-0720
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/11/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/27/2017 Patient Sequence Number: 1
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