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

Model Number	VP-900-X
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2020
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, 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.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 1219930-2020-00640
• Device Sequence Number: 14293715
• Product Code: GAW
• UDI-Device Identifier: 10884521039537
• UDI-Public: 10884521039537
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K050947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 04/29/2020; 05/04/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 04/30/2020; 05/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1