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

Lot Number J2L1082EY

Patient Problem Insufficient Information (4580)

Event Date 08/18/2023

Event Type  Injury  

Event Description

Endo stitch auto suture locking mechanism did not properly deploy.Would not release the suture, struggled with the toggles sticking when trying to open and trying to close.Tried another device and had the same issue with.Felt like the mechanism that locks and unlocks the device was the sticking.Lot numbers are the same.Reference report: mw5145116.

• Brand Name: COVIDIEN ENDO STITCH AUTO SUTURE
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 17682139
• MDR Text Key: 322820366
• Report Number: MW5145117
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: J2L1082EY
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR