MAUDE Adverse Event Report: CROSPON LTD. ENDOFLIP; SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

Model Number Y013876

Device Problem Insufficient Information (3190)

Patient Problem Perforation of Esophagus (2399)

Event Date 05/18/2017

Event Type  malfunction  

Event Description

Outpatient sustained an esophageal perforation following pneumatic dilation with an endoflip.Hospitalization and surgical intervention were required.

• Brand Name: ENDOFLIP
• Type of Device: SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)
• Manufacturer (Section D): CROSPON LTD.; paul dryden/promedic, llc; 131 bay point dr. ne; saint petersburg FL 33704
• MDR Report Key: 6763453
• MDR Text Key: 81714166
• Report Number: 6763453
• Device Sequence Number: 1
• Product Code: FFX
• 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: Other
• Type of Report: Initial
• Report Date: 06/27/2017,07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/13/2019
• Device Model Number: Y013876
• Device Lot Number: 0320170213
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/27/2017
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR