MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN V-LOC 180; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC

Model Number VLOCL0804

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 03/05/2022

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a barbed repositioning pharyngoplasty, the needle separated from the thread when the surgeon was performing a continuous suturing.The surgeon had difficulty locating the needle inside the patient's body and had to call another specialist to help with the situation.A c-arm scan was used to locate the lost needle but the patient took an additional incisions to successfully retrieve the needle.The surgery time was extended for two hours more and is completed with suturing.The patient had to extend his stay at the hospital for one day.

• Brand Name: V-LOC 180
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 13860983
• MDR Text Key: 287681680
• Report Number: 1219930-2022-00995
• Device Sequence Number: 1
• Product Code: GAM
• UDI-Device Identifier: 10884521131286
• UDI-Public: 10884521131286
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K091087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VLOCL0804
• Device Catalogue Number: VLOCL0804
• Device Lot Number: A1J0477VY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2022
• Date Device Manufactured: 09/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 74 KG