MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD NOVAFIL; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	8886440233
Medical Device Problem Codes	Failure to Fire (2610); Mechanics Altered (2984)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/24/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a laparoscopic surgery at the liver and gallbladder, the suture was incapable of firing and the surgeon was unable to squeeze the handle.They used a new instrument to complete the case.The patient was alive with no injury.
Additional Manufacturer Narrative
This event has been reassessed and found to be a non-mdr reportable complaint.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Corrected date: (date received by the manufacturer) the manufacturer was notified about the event on (b)(6) 2017.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.

• Brand Name: NOVAFIL
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 6971109
• Report Number: 9612501-2017-06474
• Device Sequence Number: 684595
• Product Code: GAT
• UDI-Device Identifier: 20884521099569
• UDI-Public: 20884521099569
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/25/2018

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: 07/31/2021
• Device Model Number: 8886440233
• Device Catalogue Number: 8886440233
• Device Lot Number: D6G0404X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/25/2017
• Supplement Date Received by Manufacturer: 02/25/2017; 11/27/2017; 11/27/2017
• Initial Report FDA Received Date: 10/24/2017
• Supplement Report FDA Received Date: 11/10/2017; 11/27/2017; 05/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR