MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SURGIPRO

Model Number	VP-511-X
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/30/2017
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 mitral valve replacement and tricuspid annuloplasty, while closing the cardiac auricle, the sutures broke three times in a row.When the extracorporeal circulatory was stopped, the suture broke again under the effect of blood pressure.They had to restart the extracorporeal circulatory and make a new suture with a device from another lot.The procedure lasted more or less than 30 min to restart the extracorporeal circulatory.

• Brand Name: SURGIPRO
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 7200153
• Report Number: 9612501-2018-00079
• Device Sequence Number: 1174246
• Product Code: GAW
• UDI-Device Identifier: 20884521037769
• UDI-Public: 20884521037769
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/17/2018

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: 06/30/2022
• Device Model Number: VP-511-X
• Device Catalogue Number: VP-511-X
• Device Lot Number: D7F1205PX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2017
• Initial Report FDA Received Date: 01/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR