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

Model Number UNKNOWN

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 02/01/2023

Event Type  malfunction  

Event Description

During surgery md was closing patient cuff and needle broke in half in pt tissue.Xray was done intraoperatively and needle was recovered and removed.

• Brand Name: ENDOSTITCH DEVICE
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 16305575
• MDR Text Key: 308973634
• Report Number: MW5114715
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/02/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White