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

Model Number	VP-743-MX
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/24/2018
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, both of the reported device had trouble of needle disconnection and thread cutting.The procedure was completed with another device.The surgical time was extended by less than 30 min.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) received one device.A tactile and microscopic inspection of the sealed sutures was performed with no ab normalities.The visual inspection of the opened sample noted four sutures and eight needles.Two sutures had a needle disengaged each.Under microscopic inspection, instrument marks were noted near the swaged end of both needles needle.Further inspection of the detached needles noted that a needle had a collapsed swage with instrument marks on both sides.A needle attachment test was performed on the sealed and untouched samples, and the results met the specifications for this product.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.The needle should always be held in the middle where the diameter is greatest.Grasping the needle near the swaged end could cause bends or breaks, or damage the connection between the needle and suture.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURGIPRO II
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 8195822
• Report Number: 9612501-2018-02277
• Device Sequence Number: 1552904
• Product Code: GAW
• UDI-Device Identifier: 10884521038875
• UDI-Public: 10884521038875
• 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,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2019

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 Expiration Date: 04/30/2023
• Device Model Number: VP-743-MX
• Device Catalogue Number: VP-743-MX
• Device Lot Number: D8D0316SX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2018
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 12/26/2018
• Supplement Report FDA Received Date: 04/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1