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

Lot Number J3D2387EY

Patient Problem Foreign Body In Patient (2687)

Event Date 10/05/2023

Event Type  malfunction  

Event Description

During procedure the vloc endostitch broke off inside patient.It was found via fluoroscopy but the surgeon was unable to retrieve it.

• Brand Name: ENDO STITCH
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 17924118
• MDR Text Key: 325806637
• Report Number: MW5146864
• Device Sequence Number: 1
• Product Code: OCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: J3D2387EY
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/11/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: V-LOC, COVIDIEN, N3A0082Y.
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Sex: Female