MAUDE Adverse Event Report: COVIDIEN SURGIDAC; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number 170044

Device Problems Mechanics Altered (2984); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 02/11/2021

Event Type  malfunction  

Event Description

The stitch did not load properly.It got stuck on the left side.

• Brand Name: SURGIDAC
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11384664
• MDR Text Key: 233740255
• Report Number: 11384664
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 170044
• Device Lot Number: J0D0407Y
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/16/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 15695 DA