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

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.

• Brand Name: CLEVER CUT 3V
• Type of Device: SINGLE USE 3 LUMEN SPHINCTEROTOME
• Manufacturer (Section D): OLYMPUS CORPORATION OF THE AMERICAS
• MDR Report Key: 7746565
• MDR Text Key: 116121634
• Report Number: MW5078841
• Device Sequence Number: 0
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 08/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/31/2021
• Device Model Number: GS1-128
• Device Lot Number: V8206
• 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