MAUDE Adverse Event Report: COVIDIEN LLC ENDO STITCH; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number 173016

Device Problems Sticking (1597); Mechanical Jam (2983)

Patient Problem No Information (3190)

Event Date 05/16/2018

Event Type  malfunction  

Event Description

The surgeon was using the endostitch and the first clip was used effectively.However, the device stuck during the next attempt and was not able to be used.A new endostitch had to be opened to finish the case.

• Brand Name: ENDO STITCH
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 7609315
• MDR Text Key: 111329733
• Report Number: 7609315
• Device Sequence Number: 1
• Product Code: OCW
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2023
• Device Model Number: 173016
• Device Catalogue Number: 173016
• Device Lot Number: J8C0064E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/13/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 06/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 128