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

Model Number	176673P
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/30/2019
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 procedure, the lens of the device disengaged.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) received a photographic investigation of a device.The first photo depicts the distal end of the optical trocar.The lens is disengaged and in pieces.The second photo depicts a full view of the device, the optical trocar lens is in three (3) pieces.Post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted; the lens for the optical trocar was broken.The fixation trocar, circular and envelop seal were received.Pmv performed functional testing: 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.Replication of the reported condition may occur when mishandled during clinical application.The root cause of the observed damage was found to be due to the device not being used as intended which caused or contributed to the reported condition.No relationship between the device and the reported incident was confirmed.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: 8916605
• Report Number: 9612501-2019-01592
• Device Sequence Number: 1812380
• Product Code: GCJ
• UDI-Device Identifier: 10884521080638
• UDI-Public: 10884521080638
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K935086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2019

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: 12/31/2023
• Device Model Number: 176673P
• Device Catalogue Number: 176673P
• Device Lot Number: J9A0683Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 10/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1