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

Model Number	VLOCL0814
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a cesarean section, when the doctor had the needle go through the loop and tied it up, the loop broke.Nothing fell into the patient's cavity and the operating time not extended.The procedure was completed with another device.The status of the patient is alive with no injury.
Additional Manufacturer Narrative
We have requested for the product to be returned.We will be sending another report once we have received and evaluated the device.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, per additional information received during a cesarean section, when the package was opened it was noticed that the loop was broken and not during the procedure.The procedure was completed with another device.The status of the patient is alive with no injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the sample noted 1 suture and 1 needle.Microscopic inspection of the loop noted material transfer which is an indication that the loop was welded.This serves as evidence that the loop was broken under tension; however, since the sample was received with the loop open, the force required to break the loop cannot be determined.Additionally, the foil was inspected with light assisted microscopy with no abnormalities.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: V-LOC 180
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN NORTH HAVEN - MFG; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 6973870
• Report Number: 1219930-2017-08201
• Device Sequence Number: 16267857
• Product Code: GAM
• UDI-Device Identifier: 20884521131320
• UDI-Public: 20884521131320
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K091087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: VLOCL0814
• Device Catalogue Number: VLOCL0814
• Device Lot Number: A7F0160VX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2017
• Initial Date Received by Manufacturer: 10/20/2017
• Supplement Date Received by Manufacturer: 10/31/2017; 01/05/2018
• Initial Report FDA Received Date: 10/24/2017
• Supplement Report FDA Received Date: 11/07/2017; 01/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1