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

Model Number	VLOCM1904
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); No Consequences Or Impact To Patient (2199); Radiation Exposure, Unintended (3164)
Date of Event	10/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, intra-operatively, the device needle fell into patient's abdomen and got stuck in the peritoneum.Due to the location of the needle, the surgeon decided to retain it inside and allowed to migrate.Surgeon ordered an x-ray for the patient and verified the device retained inside.

• Brand Name: V-LOC 90
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN NORTH HAVEN-MFG; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7105741
• Report Number: 1219930-2017-09813
• Device Sequence Number: 1351437
• Product Code: GAM
• UDI-Device Identifier: 10884521132917
• UDI-Public: 10884521132917
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K100257
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: VLOCM1904
• Device Catalogue Number: VLOCM1904
• Device Lot Number: A6G0411VX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 12/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention