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

Model Number	NB15LGF
Medical Device Problem Codes	Detachment Of Device Component (1104); Leak/Splash (1354); Noise, Audible (3273)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/25/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter: occurred during a laparoscopic gastric bypass procedure.The port was placed into the patient.The surgeon was using 5mm instruments through the reducer cap and opening / closing as needed for 10mm or 15mm instruments / staplers.Early on in the case, noted more than usual sound of escaping gas from port.Checked valves on trocars not connected to insufflation, all ports closed.There was no leaking noted at the trocar incision sites.Shortly thereafter (under laparoscopic view), the surgeon observed a circular opaque white foreign object in the abdomen.Examined the 5-15mm cap and discovered that the seal was absent from the cap.The 5-15 mm seal disengaged and fell into the cavity of the patient.The surgeon was able to retrieve the seal.In order to resolve the issue and complete the case, replaced with a new 5-15mm reducer cap.There was no patient harm.The patient outcome is alive, 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 the seal from the reducer cap was disengaged.The cannula, envelope seal and circular seal appeared intact.Pmv performed functional testing; the device 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 or component related failures.Replication of the disengaged reducer cap seal may occur when mishandled during clinical application.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 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: 6971696
• Report Number: 9612501-2017-06476
• Device Sequence Number: 16265607
• Product Code: GCJ
• UDI-Device Identifier: 20884521076522
• UDI-Public: 20884521076522
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K081169
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2017

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 Model Number: NB15LGF
• Device Catalogue Number: NB15LGF
• Device Lot Number: J6E2286X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2017
• Initial Date Received by Manufacturer: 09/27/2017
• Supplement Date Received by Manufacturer: 11/28/2017
• Initial Report FDA Received Date: 10/24/2017
• Supplement Report FDA Received Date: 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1