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

Model Number VLOCA208L

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

Patient Problem Foreign Body In Patient (2687)

Event Date 04/22/2022

Event Type  malfunction  

Event Description

Narrative from staff: during the use of endo stick lock with v-loc suture the needle broke in half and half of the needle is retained in the patient.Representative was in the or at the time of the event, and it has been determined it's a faulty lot.Narrative from operative report: x-ray performed to confirm suspected retained 4mm section of endo stick needle.This material could not be seen within the pelvis for retrieval.Manufacturer response for autosuture endo stitch 10mm, (brand not provided) (per site reporter) see note on previous device listed.Manufacturer response for suture, absorbable, synthetic, polyglycolic acid, v-loc 180 (per site reporter) personnel from manufacturer was in the or at the time of the event and it has been determined that the lot is a faulty lot.Lot was pulled and new lot ordered.This is the 4th event we have reported since january 2022.

• Brand Name: V-LOC 180
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 14257427
• MDR Text Key: 290453693
• Report Number: 14257427
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VLOCA208L
• Device Catalogue Number: VLOCA208L
• Device Lot Number: N2A0110Y
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/26/2022
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 11680 DA
• Patient Sex: Female
• Patient Weight: 61 KG