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

Model Number	176673PF
Medical Device Problem Codes	Break (1069); Detachment Of Device Component (1104)
Health Effect - Clinical Codes	Radiation Exposure, Unintended (3164); No Code Available (3191)
Date of Event	11/27/2017
Type of Reportable Event	Serious Injury
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 sleeve gastrectomy laparoscopic procedure, the device¿s lens was disengaged while being applied on placement of trocars.The surgeon inflated cavity using normal needle insufflation.He was firing the trocar through the mid fascia with no difficulties with no prior incision and no mesh involved.As obturator and camera were removed from the sleeve, it was notice that two wire guides sprung open on the side of the obturator.It was also notice that the glass at the end of the obturator was missing.They inspected inside the cavity showed two pieces of broken glass that were removed laparoscopically.A third piece of glass was found attached to the fascia and was removed laparoscopically.Also several very small prices of metal were seen and removed laparoscopically.The blade however was not visible.The site was extended slightly in order to look for the blade within the abdominal tissue.Three x-rays covering the full abdomen were taken with no indication of the metal blade.Ultimately the blade was found on the floor of the nurse.Surgery time was extended by 120 minutes.Procedure was completed normally using a blunt tip troc ar in place of the visiport cannula.No part of the camera was damaged and the same camera was used throughout the case.Patient is alive with no loss of tissue and just a slightly increased incision surrounding that initial site.
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 lens was disengaged from the device.The lens was received in a sample jar.The cannula, trocar, envelope and circular seal appeared intact.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 disengaged lens 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: 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: 7140605
• Report Number: 9612501-2017-06784
• Device Sequence Number: 19164537
• Product Code: GCJ
• UDI-Device Identifier: 20884521080642
• UDI-Public: 20884521080642
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K935086
• 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): 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 176673PF
• Device Catalogue Number: 176673PF
• Device Lot Number: J7G2585X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Initial Date Received by Manufacturer: 11/27/2017
• Supplement Date Received by Manufacturer: 12/19/2017
• Initial Report FDA Received Date: 12/21/2017
• Supplement Report FDA Received Date: 01/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR