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

Model Number 173016

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/02/2023

Event Type  malfunction  

Event Description

During laparoscopic conversion sleeve to gastric bypass roux-en-y on [redacted date], the attending and surgical fellow were using the endostitch when 10mm endopath suture device broke.Approximately half of a 0 ethibond needle was left in patient and it could not be located by the surgeon.Final count recorded as incorrect to account for the discrepancy and x-ray obtained post operatively per policy.Endopath device secluded in bio bag and ultimately provided to company representative.

• Brand Name: ENDO STITCH
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN; 60 middletown ave; north haven CT 06473
• MDR Report Key: 16973366
• MDR Text Key: 315670912
• Report Number: 16973366
• 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: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 173016
• Device Catalogue Number: 173016
• Device Lot Number: J2K0140EY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/11/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/22/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22995 DA
• Patient Sex: Male
• Patient Weight: 125 KG
• Patient Race: White