MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN V-LOC 90; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	VLOCM0013
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/22/2018
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 an open lobectomy-mammae, when closing the fat, the thread broken at the place where it is fixed to the needle and it happened twice.They took a new suture to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) received two devices opened by the account and two sealed representative samples.A tactile and microscopic inspection of the sutures was performed with no abnormalities.The visual inspection of the opened sample noted no sutures and two needles.The needles were returned disengaged from the sutures.Under microscopic inspection, instrument marks were noted near the swaged end of the needles.A needle attachment test was performed on the sealed samples, and the results met the specifications for this product.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.Grasping the needle at the swaged end can cause the needle to break, bend, or become disengaged from the suture.The needle should always be grasped in the middle, where the diameter is greatest.If information is provided in the future, a supplemental report will be issued.

• Brand Name: V-LOC 90
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7865721
• Report Number: 1219930-2018-04957
• Device Sequence Number: 1720253
• Product Code: GAM
• UDI-Device Identifier: 20884521131641
• UDI-Public: 20884521131641
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K100257
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2018

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: 05/31/2021
• Device Model Number: VLOCM0013
• Device Catalogue Number: VLOCM0013
• Device Lot Number: A8E0364VFX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 12/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR