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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 VLOCL1544
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
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, while the surgeon was employing a continuous suturing technique in the beginning of the closure during a laparoscopic gastric bypass, the suture thread broke and could not be used.They took a new suture to complete the case.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 06473
MDR Report Key7503075
Report Number1219930-2018-02584
Device Sequence Number16380029
Product Code GAM
UDI-Device Identifier10884521131460
UDI-Public10884521131460
Combination Product (Y/N)N
Initial Reporter CountryNL
PMA/510(K) Number
K091087
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 05/10/2018
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 Date12/31/2020
Device Model NumberVLOCL1544
Device Catalogue NumberVLOCL1544
Device Lot NumberA7M0986VX
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/03/2018
Initial Report FDA Received Date05/10/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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