MAUDE Adverse Event Report: COVIDIEN SUTURE: VLOC 180, SIZE0.8; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

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

Patient Problem Foreign Body In Patient (2687)

Event Date 08/10/2022

Event Type  malfunction  

Event Description

Zero 8cm endostitch needle broke during use.Part of the needle was removed from the body, but the other half (about 0.4cm) was unable to be located.X-ray came and took x-rays of the area.The needle was located near the cuff, according to the surgeon.The surgeon indicated that the needle could not be removed, but that it would cause no complications.The surgeon notified the patient's family of the retained needle event.Fda safety report id #(b)(4).

• Brand Name: SUTURE: VLOC 180, SIZE0.8
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 15217178
• MDR Text Key: 297953157
• Report Number: MW5111457
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• 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: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 130 KG
• Patient Race: White