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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 VLOCL0305
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 11/08/2017
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 robotic procedure, as soon as they inserted, the suture detached from the needle.There was no injury caused to the patient and no medical intervention was required.
 
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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 mc dermott rd
north haven CT 06473
MDR Report Key7047379
Report Number1219930-2017-08964
Device Sequence Number16607290
Product Code GAM
UDI-Device Identifier20884521130934
UDI-Public20884521130934
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
K091087
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 11/20/2017
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 Date08/31/2020
Device Model NumberVLOCL0305
Device Catalogue NumberVLOCL0305
Device Lot NumberA7H0519VX
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/08/2017
Initial Report FDA Received Date11/20/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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