MAUDE Adverse Event Report: COVIDIEN ENDOSTITCH SUTURING DEVICE (10MM); ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number 173016

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/22/2019

Event Type  Injury  

Event Description

Piece of needle broke off from the suturing device during use.After a pass of device, noticed the piece of needle was missing.During previous pass of device, surgeon described difficulty in getting the device open.Did get device open after some struggle / more effort than normal.

• Brand Name: ENDOSTITCH SUTURING DEVICE (10MM)
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 8848012
• MDR Text Key: 153133760
• Report Number: MW5088589
• 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: Other
• Type of Report: Initial
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 173016
• Device Catalogue Number: 173016
• Device Lot Number: 9A2765EY
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR