MAUDE Adverse Event Report: BOSTON SCIENTIFIC; ENDOSCOPIC ELECTROSURGICAL UNIT

Device Problem Failure to Cut (2587)

Patient Problem No Information (3190)

Event Date 05/24/2017

Event Type  malfunction  

Event Description

During an endoscopic retrograde cholangio-pancreatography (ercp), when a sphincterotomy was attempted, the erbe didn't cut right.The physician described it as more of a burn than a cut.All settings and connections were checked and everything was appropriate.Tried one more time and the same result.Staff stopped trying and moved on to a balloon sweep.A 9mm balloon was able to pass through the opening.

• Type of Device: ENDOSCOPIC ELECTROSURGICAL UNIT
• Manufacturer (Section D): BOSTON SCIENTIFIC; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 6662949
• MDR Text Key: 78278746
• Report Number: 6662949
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/19/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/19/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 42 YR