MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SOFSILK; ENDOSCOPIC TISSUE APPROXIMATION DEVICE

Model Number	170003
Medical Device Problem Codes	Detachment Of Device Component (1104); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/16/2016
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, during a paraesophageal hiatus hernia repair, the suture came off device.Suture would not load for 2nd and 3rd device.No patient injury or ill-effects.No medical intervention required.Patient current status reported as recovered.
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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: post marketing vigilance (pmv) received three devices.No needle was returned with the instrument.Witness marks on the bevel wall were observed for all three instruments.No sheering on the toggle switches was observed for either instrument.The instrument was loaded with a needle from the pmv inventory and applied to test media.Pressure was exerted on the needle in all directions from both sides of the jaws during this test in an effort to simulate clinical conditions.The instrument was found to function properly and each needle remained intact.No difficulty was experienced in loading, unloading, or toggling the needle.Visual and functional testing of the returned sample confirmed the product met quality release specifications.A review of the device history record indicates this device lot number was released meeting all quality release specifications at the time of manufacture the most probable root cause is improper orientation of the needle in the reload.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SOFSILK
• Common Device Name: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 6558740
• Report Number: 9612501-2017-05477
• Device Sequence Number: 16506448
• Product Code: OCW
• UDI-Device Identifier: 20884521126890
• UDI-Public: 20884521126890
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K934738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/30/2017

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: 170003
• Device Catalogue Number: 170003
• Device Lot Number: J6J2708X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Initial Date Received by Manufacturer: 11/17/2016
• Supplement Date Received by Manufacturer: Not provided; 05/09/2017; 11/01/2017
• Initial Report FDA Received Date: 05/10/2017
• Supplement Report FDA Received Date: 05/11/2017; 09/07/2017; 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1