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

Model Number	NB5STF
Medical Device Problem Codes	Device Packaging Compromised (2916); Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/09/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, pre-operatively laparoscopic radical nephrectomy, while preparing to open the trocar for puncturing, the seal was damaged on the product packaging.They changed the surgical instruments to complete the case.The patient had no injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted; trocar, cannula and circular seal appeared intact.The obturator was received inserted into the cannula; prolonged insertion can cause the envelope seal to become stretched.Pmv performed functional testing: the port failed an air leak test.The obturator was inserted and removed from the cannula cleanly.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.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: VERSAPORT
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 7152420
• Report Number: 9612501-2017-06848
• Device Sequence Number: 16353913
• Product Code: GCJ
• UDI-Device Identifier: 10884521076747
• UDI-Public: 10884521076747
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K100548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2018

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: NB5STF
• Device Catalogue Number: NB5STF
• Device Lot Number: J6G1892X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2018
• Initial Date Received by Manufacturer: 12/12/2017
• Supplement Date Received by Manufacturer: 03/03/2018
• Initial Report FDA Received Date: 12/28/2017
• Supplement Report FDA Received Date: 03/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1