MAUDE Adverse Event Report: COVIDIEN LP V-LOC 180; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number V-LOC 180

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

Patient Problem Foreign Body In Patient (2687)

Event Date 05/25/2022

Event Type  malfunction  

Event Description

V-loc suture needle broke off when in use, unable to retrieve the remnant from patient.Fluoroscopy (c-arm) was negative for radiopaque items, no retained items identified by radiologist.Fda safety report id# (b)(4).

• Brand Name: V-LOC 180
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN LP
• MDR Report Key: 14547704
• MDR Text Key: 293146039
• Report Number: MW5109984
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V-LOC 180
• Device Catalogue Number: VLOCA006L
• Device Lot Number: N2D0068Y
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White