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

Model Number	SP-5698
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	11/14/2017
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, during sclerotherapy of varicose veins procedure, one hour of procedure, the device's needle and thread was broken.In the first point of the suture the needle was disassembled from the thread.The suture was treated/hydrated with serum prior to use.They used another device to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary post market vigilance (pmv) led an evaluation of one device.The visual inspection of the sample noted 1 suture and 1 needle.The needle was observed to be detached from the suture.The needle was bent.Upon microscopic inspection of the needle, normal needle crimp and swage marks were observed on the needle.Upon microscopic inspection of the needle, instrument marks were noted on the tip and bend site.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.Replication of this damage may occur by grasping the needle improperly which can damage the needle as observed.It is recommended that the needle be grasped from the needle body, where the wire is of a full diameter and significantly stronger.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 LL
• 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: 7088028
• Report Number: 9612501-2017-06707
• Device Sequence Number: 13669163
• Product Code: GAW
• UDI-Device Identifier: 20884521036991
• UDI-Public: 20884521036991
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2018

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: 09/30/2021
• Device Model Number: SP-5698
• Device Catalogue Number: SP-5698
• Device Lot Number: D6J2406X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Initial Date Received by Manufacturer: 11/14/2017
• Supplement Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 02/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1