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

Model Number VP-900-X

Device Problems Break (1069); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, while doing vessel anastomosis during coronary artery bypass graft, the suture and needle diverged and the needle bended in tissue.Another suture was used to complete the case.There was no patient injury.

Manufacturer Narrative

Additional information: d3(mfr name, street 1, mfr city, country code, postal code), d10, g4, h3, h6 h3 evaluation summary: post market vigilance (pmv) received one device.A tactile and microscopic inspection of the sutures was performed with no abnormali ties.The needles were received unbent with no abnormalities.A needle attachment test was performed on the sealed samples, and the results met the specifications for this product.There were not enough samples returned to perform a bend moment test.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 investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: g4, h3 h3 evaluation summary: post market vigilance (pmv) received three devices.A tactile and microscopic inspection of the sutures was performed with no abnorm alities.The needles were received unbent with no abnormalities.A needle attachment test and a bend moment test were performed on the sealed samples, and the results for both tests 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 i nvestigation concluded there were no abnormalities that would have caused or contributed to the reported condition if information is provided in the future, a supplemental report will be issued.

• Brand Name: SURGIPRO LL
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo CT 0101 ; DO 0101
• MDR Report Key: 9687166
• MDR Text Key: 178382449
• Report Number: 1219930-2020-00640
• Device Sequence Number: 1
• Product Code: GAW
• UDI-Device Identifier: 10884521039537
• UDI-Public: 10884521039537
• Combination Product (y/n): N
• PMA/PMN Number: K050947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/05/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: VP-900-X
• Device Catalogue Number: VP-900-X
• Device Lot Number: D9B1666SY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Initial Date Manufacturer Received: 01/27/2020
• Initial Date FDA Received: 02/10/2020
• Supplement Dates Manufacturer Received: 04/29/2020; 05/04/2020
• Supplement Dates FDA Received: 04/30/2020; 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1