MAUDE Adverse Event Report: MEDTRONIC/COVIDIEN MEDTRONIC/COVIDIEN ENDOSTITCH DEVICE; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Lot Number J9L0758EY

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/22/2021

Event Type  malfunction  

Event Description

While using the endo stitch and v-loc 180 during a lavh the needle broke.It was seen on x-ray but the piece was unable to be located and retrieved.Fda safety report id # (b)(4).

• Brand Name: MEDTRONIC/COVIDIEN ENDOSTITCH DEVICE
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): MEDTRONIC/COVIDIEN; minneapolis MN 55432 5604
• MDR Report Key: 12107991
• MDR Text Key: 260145085
• Report Number: MW5102261
• Device Sequence Number: 1
• Product Code: OCW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/28/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: J9L0758EY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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): Other
• Patient Age: 48 YR