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

Model Number	176674P
Medical Device Problem Code	Device Packaging Compromised (2916)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/12/2017
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 hernia, the device's seal was damaged.Scrub technician opened the device and it was broken.A new device was used to complete the case.There was no injury caused to the patient and no medical intervention was required.
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 optical trocar and lens appeared intact.The cannula, fixation trocar, circular were received.The envelope seal was stretched and open.The white gasket seal for the trocar was disengaged and not received.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.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: VISIPORT PLUS
• 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: 7018142
• Report Number: 9612501-2017-06557
• Device Sequence Number: 16563200
• Product Code: GCJ
• UDI-Device Identifier: 10884521080652
• UDI-Public: 10884521080652
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K935086
• 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
• Report Date (Section B): 02/05/2018

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: 06/30/2021
• Device Model Number: 176674P
• Device Catalogue Number: 176674P
• Device Lot Number: J6F2745X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2017
• Initial Date Received by Manufacturer: 10/13/2017
• Supplement Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 11/10/2017
• Supplement Report FDA Received Date: 02/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1