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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN V-LOC; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
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COVIDIEN LP LLC NORTH HAVEN V-LOC; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE Back to Search Results
Model Number VLOCN0615
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 11/11/2017
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, intra-operatively, while over sewing the stomach with the device, the suture detached without the surgeon using any pressure or tension on the suture.Another device was opened and the same problem occurred.Patient was not injured or jeopardized.
 
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Brand Name
V-LOC
Common Device Name
SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
Manufacturer (Section D)
COVIDIEN LP LLC NORTH HAVEN
195 mc dermott rd
north haven CT 06473
MDR Report Key7082493
Report Number1219930-2017-09349
Device Sequence Number782293
Product Code GAT
UDI-Device Identifier20884521135298
UDI-Public20884521135298
Combination Product (Y/N)N
Initial Reporter CountryLE
PMA/510(K) Number
K111442
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,other,user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 12/05/2017
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 Date02/29/2020
Device Model NumberVLOCN0615
Device Catalogue NumberVLOCN0615
Device Lot NumberA7B0667VX
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/12/2017
Initial Report FDA Received Date12/05/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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