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

Model Number	176673PF
Medical Device Problem Code	Device Packaging Compromised (2916)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/23/2018
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, pre operatively, the knife was not difficult to advance, the lens did not disengage and the seal was damaged.There was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted; the optical trocar and lens appeared intact.The fixation trocar, circular and envelop seals were received.Pmv performed functional testing: when the trigger was actuated, the knife blade advanced and cut through the test media.The port passed 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.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: 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: 7584021
• Report Number: 9612501-2018-01082
• Device Sequence Number: 13948103
• Product Code: GCJ
• UDI-Device Identifier: 10884521080645
• UDI-Public: 10884521080645
• 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: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2018

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: 04/30/2021
• Device Model Number: 176673PF
• Device Catalogue Number: 176673PF
• Device Lot Number: J6D0077X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Initial Date Received by Manufacturer: 05/23/2018
• Supplement Date Received by Manufacturer: 07/11/2018; 08/08/2018
• Initial Report FDA Received Date: 06/08/2018
• Supplement Report FDA Received Date: 07/26/2018; 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1