MAUDE Adverse Event Report: COVIDIEN ENDO STITCH VLOC 10MM ENDO STITCH DEVICE; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number A008L

Device Problems Break (1069); Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Md began suturing utilizing a 10mm endo stitch device ref # 173016 with vloc a008l lot # n1a0958y- during procedure suturing material broke with needle attached to device.When removed from the patient, a portion of the vloc needle (approximately 1-2mm) was missing.Md conducted a cavity search with no portion of the needle located.Fda safety report id # (b)(4).

• Brand Name: ENDO STITCH VLOC 10MM ENDO STITCH DEVICE
• Type of Device: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 11900778
• MDR Text Key: 253727778
• Report Number: MW5101605
• Device Sequence Number: 2
• 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: 05/25/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: A008L
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1