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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS CORPORATION OF THE AMERICAS CLEVER CUT 3V SINGLE USE 3 LUMEN SPHINCTEROTOME

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OLYMPUS CORPORATION OF THE AMERICAS CLEVER CUT 3V SINGLE USE 3 LUMEN SPHINCTEROTOME Back to Search Results
Model Number GS1-128
Device Problem Break (1069)
Patient Problem Laceration(s) (1946)
Event Date 07/23/2018
Event Type  Injury  
Event Description
An ercp was attempted on (b)(6) 2018 for palliative stenting of the biliary duct. During the sphincterotomy, the cutting wire in the papillotome broke and the proximal portion of the wire lacerated the duodenal wall. Immediate inspection and repair of duodenum was completed with clips. The rest of the procedure was aborted and the pt was left intubated and transferred to the icu for close supervision.
 
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Brand NameCLEVER CUT 3V
Type of DeviceSINGLE USE 3 LUMEN SPHINCTEROTOME
Manufacturer (Section D)
OLYMPUS CORPORATION OF THE AMERICAS
MDR Report Key7746565
MDR Text Key116121634
Report NumberMW5078841
Device Sequence Number0
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2021
Device Model NumberGS1-128
Device Lot NumberV8206
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/02/2018 Patient Sequence Number: 1
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