MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD VERSAPORT PLUS; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	179078PF
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted that the cannula, trocar and circular seal appeared intact.The duckbill seal was stretched out.The obturator was received inserted into the cannula.Prolonged insertion can cause the envelope seal to become stretched and the port failed an air leak test.Pmv performed functional testing: when the trigger was actuated, the knife blade advanced and cut through the test media.The port failed an air leak test.Functional testing was performed and when the trigger was actuated, the knife blade advanced and cut through the test media.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 secondary finding of the port which failed an air leak test is not related to the reported condition.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during sleeve gastrectomy, the trocar was locked in the safety position.The blade does not come out and cannot perforate the patient¿s abdominal wall.Another device was used to complete the case.There was no patient injury.

• Brand Name: VERSAPORT PLUS
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 18750 ; DO 18750
• MDR Report Key: 8504890
• Report Number: 9612501-2019-00762
• Device Sequence Number: 16900561
• Product Code: GCJ
• UDI-Device Identifier: 10884521082687
• UDI-Public: 10884521082687
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K062326
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/11/2019

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: 06/30/2023
• Device Model Number: 179078PF
• Device Catalogue Number: 179078PF
• Device Lot Number: J8F1134X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1