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

Model Number	173023
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	04/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a laparoscopic roux en y procedure, the surgeon was closing the space of defect and as they were toggling, the suture ripped off the needle.Another loading unit was opened and used to complete the procedure.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The needle was found to be bent.In addition (pmv) performed photographic evaluation of one image and the visual inspection of the returned photo noted that the image show only the packaging of suture.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the bent needle may occur when the needle is not loaded properly or when the needle is forced into an obstacle.This condition may also occur if excess pressure is exerted on the needle or the attached suture while the jaws are in the open position.In these situations, the needle may flex and ultimately break and also will damage the connection between the needle and suture.The root cause of the observed damage was due to the product not being used as intended which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURGIDAC
• Common Device Name: ENDOSCOPIC TISSUE APPROXIMATION DEVICE
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 18750 ; DO 18750
• MDR Report Key: 8626077
• Report Number: 9612501-2019-00991
• Device Sequence Number: 11304979
• Product Code: OCW
• UDI-Device Identifier: 20884521129440
• UDI-Public: 20884521129440
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K934738
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2019

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: 10/31/2023
• Device Model Number: 173023
• Device Catalogue Number: 173023
• Device Lot Number: J8K0879X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Initial Date Received by Manufacturer: 04/30/2019
• Supplement Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 08/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1