MAUDE Adverse Event Report: COVIDIEN NORTH HAVEN - MFG SURGIPRO II; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	VP-744-MX
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	01/16/2018
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 coronary bypass procedure, the thread broke in a row.The surgical time was extended by more than 30 min.No patient harm reported.
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 coronary bypass procedure, the thread broke in a row.The procedure was completed with another device.The surgical time was extended by more than 30 min.No patient harm reported.The current status of the patient is no problem.

• Brand Name: SURGIPRO II
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): COVIDIEN NORTH HAVEN - MFG; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7230518
• Report Number: 1219930-2018-00556
• Device Sequence Number: 11091934
• Product Code: GAW
• UDI-Device Identifier: 20884521038889
• UDI-Public: 20884521038889
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2018

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 Date: 01/31/2022
• Device Model Number: VP-744-MX
• Device Catalogue Number: VP-744-MX
• Device Lot Number: A7A0055X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/17/2018
• Supplement Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 01/31/2018
• Supplement Report FDA Received Date: 02/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1