MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SOFSILK; SUTURE, NONABSORBABLE, SILK

Model Number	GS-63-M
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: occurred during a laparoscopic procedure.The device package had six needles and sutures but it should only have five.The patient is alive with no injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the sample noted six sutures and six needles.The packaging indicates that there should only be five sutures and needles.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.The root cause of the additional product was determined to be due to manpower error.The product analysis established a relationship between a device failure and the reported incident of additional suture.The root cause of the observed condition was determined to be a result of a manufacturing activity and a process improvement has been implemented to prevent this condition from recurring.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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Post market vigilance (pmv) received one device.The visual inspection of the returned product noted that the visual inspection of the sample noted six sutures and six needles.The packaging indicates that there should only be five sutures and needles.Forwarded to engineering for further evaluation of extra suture.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SOFSILK
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 6736127
• Report Number: 9612501-2017-05843
• Device Sequence Number: 1508700
• Product Code: GAP
• UDI-Device Identifier: 10884521085077
• UDI-Public: 10884521085077
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K981128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/15/2018

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: 10/31/2021
• Device Model Number: GS-63-M
• Device Catalogue Number: GS-63-M
• Device Lot Number: D6K2712X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Initial Date Received by Manufacturer: 06/28/2017
• Supplement Date Received by Manufacturer: 07/06/2017; 01/05/2018; 02/13/2018
• Initial Report FDA Received Date: 07/24/2017
• Supplement Report FDA Received Date: 08/04/2017; 02/02/2018; 03/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1