MAUDE Adverse Event Report: COVIDIEN LP ENDOSTITCH; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number 173016

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/22/2016

Event Type  malfunction  

Event Description

When using surgidac suture, the needle came off of the device.It was reloaded inside of the patient and then the needle broke off of the suture strand as the device was removed from the trocar.Initially, it was thought the needle was lost in patient's abdomen but found minutes later.

• Brand Name: ENDOSTITCH
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN LP; 60 middletown ave.; north haven CT 06473
• MDR Report Key: 6221217
• MDR Text Key: 63831444
• Report Number: 6221217
• 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: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2021
• Device Model Number: 173016
• Device Catalogue Number: 173016
• Device Lot Number: J6E1808X
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/19/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT APPLICABLE ; NOT APPLICABLE
• Patient Age: 58 YR
• Patient Weight: 132