MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SURGIPRO II; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number VP-761-X

Device Problems Break (1069); Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problems Failure to Anastomose (1028); Tissue Damage (2104); No Known Impact Or Consequence To Patient (2692)

Event Date 06/02/2017

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the customer noticed that the suture broke, needles were also found to be deformed.There was patient suture bleeding.The surgical time was extended by more than 30 minutes.There was tissue damage but it was not permanent.The surgeon/doctor repaired and made a new suture line in order to resolve the issue.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURGIPRO II
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7702660
• MDR Text Key: 114771017
• Report Number: 9612501-2018-01330
• Device Sequence Number: 1
• Product Code: GAW
• UDI-Device Identifier: 20884521039145
• UDI-Public: 20884521039145
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K050947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: VP-761-X
• Device Catalogue Number: VP-761-X
• Device Lot Number: D6J2668X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/21/2018
• Initial Date FDA Received: 07/19/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/03/2018
• Date Device Manufactured: 09/26/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention