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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN V-LOC 180; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
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COVIDIEN LP LLC NORTH HAVEN V-LOC 180; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID Back to Search Results
Model Number VLOCL1413
Medical Device Problem Codes Break (1069); Detachment Of Device Component (1104)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 04/19/2018
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 a wedge/segmental resection, when a doctor had the needle go through the loop and pulled up the thread, the loop broke.The part fell into the patient's cavity and was retrieved.The procedure was completed with another device.There was no patient injury.
 
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Brand Name
V-LOC 180
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 Key7472746
Report Number1219930-2018-02354
Device Sequence Number16452095
Product Code GAM
UDI-Device Identifier10884521131453
UDI-Public10884521131453
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K091087
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/30/2018
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 Model NumberVLOCL1413
Device Catalogue NumberVLOCL1413
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/20/2018
Initial Report FDA Received Date04/30/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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