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

Model Number	VP-734-MX
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	12/21/2018
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, on a coronary bypass, during suturing, the needle and the thread of the two sutures used were easily disengaged.Another device was used to complete the case.There was no patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, about 3 hours into a coronary bypass, during suturing using continuous suture technique for vascular anastomosis, the needle and the thread of the two sutures used were easily disengaged.Another device was used to complete the case.There was no patient injury.

• Brand Name: SURGIPRO II
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 8300539
• Report Number: 1219930-2019-00665
• Device Sequence Number: 1303862
• Product Code: GAW
• UDI-Device Identifier: 20884521038797
• UDI-Public: 20884521038797
• 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): 03/01/2019

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 Number: VP-734-MX
• Device Catalogue Number: VP-734-MX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/21/2018
• Supplement Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 02/03/2019
• Supplement Report FDA Received Date: 03/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1