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

Model Number	VP-541X
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, the incident sample has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, one side of the needle had come off the thread.No injury.
Additional Manufacturer Narrative
Evaluation summary post market vigilance (pmv) led an evaluation of one device.The visual inspection of the sample noted a partial suture and two needles.One of the needles was observed to be detached from the suture.The other needle was attached to the partial suture.Upon microscopic inspection of the needles, normal needle crimp and swage marks were observed on the needle.It was observed, under magnification, that instrument marks were present on the needle body close to the swaged end of both needles.The retainer was inspected with no abnormalities.As no sealed products were returned, functional testing was precluded.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 observed instrumentation damages suggested that the needles were grasped improperly at the swaged end of the needle during application.Firmly grasping the needle at the swaged end can deform the crimp and cause the needle to disengage from the suture.The recommended grasping area of the needle is at the needle body, where the wire is of a full diameter.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.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: 7073719
• Report Number: 9612501-2017-06675
• Device Sequence Number: 16458729
• Product Code: GAW
• UDI-Device Identifier: 10884521037847
• UDI-Public: 10884521037847
• 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,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2018

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: 04/30/2020
• Device Model Number: VP-541X
• Device Catalogue Number: VP-541X
• Device Lot Number: D5D0802X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2017
• Initial Date Received by Manufacturer: 11/02/2017
• Supplement Date Received by Manufacturer: 02/08/2018
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 02/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1