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

Model Number 173016

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/29/2020

Event Type  Injury  

Event Description

Surgeon performing total lap hysterectomy, and vaginal cuff closure vaginally.The vaginal cuff was sutured with an endostitch device, and during the closure of the vaginal cuff, a portion of the 9mm endostitch device incorporated into the vaginal cuff.Cuff closure laparoscopically aborted and attention was made to continue closure vaginally.An x-ray and ct were performed, noted a 6 mm metallic fragment positioned within the central vaginal cuff.Interventional radiology consulted to discuss isolation and localization of the needle tip.Surgeon consulted interventional radiologist, collaboratively planned to see patient as an outpatient in a week.Fda safety report id # (b)(4).

• Brand Name: ENDOSTITCH AUTO SUTURE
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 10777789
• MDR Text Key: 214541531
• Report Number: MW5097610
• Device Sequence Number: 1
• Product Code: OCW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• 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: J0B0413EY
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR