MAUDE Adverse Event Report: COVIDIEN (MEDTRONIC) ENDOSTITCH; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number 173016

Device Problems Detachment Of Device Component (1104); Unintended Movement (3026)

Patient Problem No Information (3190)

Event Date 09/19/2016

Event Type  malfunction  

Event Description

The endostitch would release the needle when not wanted to release and does not release the needle when wanted to release.

• Brand Name: ENDOSTITCH
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN (MEDTRONIC); 60 middletown ave.; north haven CT 06473
• MDR Report Key: 6128550
• MDR Text Key: 60920251
• Report Number: 6128550
• Device Sequence Number: 1
• Product Code: MFJ
• 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: 10/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 173016
• Device Catalogue Number: 173016
• Device Lot Number: J6G0087X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2016
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/18/2016
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1