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

Model Number	176674PF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blood Loss (2597); No Code Available (3191)
Date of Event	06/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: occurred during a laparoscopic gastric sleeve procedure.The surgeon used the device with a laparoscope to gain entry into the abdomen.The surgeon made a small incision and the device was pushed against the skin.The device was fired multiple times, cutting through layers of fat and muscle.When the device handle was removed and the laparoscope was introduced through the cannula into the abdominal cavity, visibility inside the abdomen was lost due to what appeared to be bleeding.Following several attempts, the lens of the laparoscope was unable to cleared due to what appeared to be substantial bleeding from the abdominal cavity.The insufflator was turned off but visibility was not improved.There was a substantial decrease in blood pressure and two additional surgeons were called to assist.The patient received several bags of blood transfusions and received what appeared to be an external cardiac massage by the anesthetist.After approximately twenty minutes, bleeding was successfully arrested by packing and clamping the injured blood vessel (emergency laparotomy was performed).It was stated that the patient suffered massive blood loss due to an injury to a major blood vessel.The incision was extended to more than 1inch.A vascular surgeon was called and the decision was made to transfer the patient to a different hospital.At that point, the patient was stable according to surgical staff but had a permanent injury.The patient also had an extended hospital stay and the case could not be completed due to the incident.
Additional Manufacturer Narrative
Post market vigilance (pmv) led an evaluation of one device.The event report alleges that the product was used in a surgical procedure.The visual inspection of the returned product noted; the optical trocar, lens, fixation trocar, circular and envelop seal all appeared intact.Pmv performed functional testing of the device: 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; therefore.Our investigation was unable to determine a root cause or establish a relationship between the devices and the reported incident.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: 6740845
• Report Number: 9612501-2017-05853
• Device Sequence Number: 16351793
• Product Code: GCJ
• UDI-Device Identifier: 20884521080765
• UDI-Public: 20884521080765
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2017

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: 12/31/2021
• Device Model Number: 176674PF
• Device Catalogue Number: 176674PF
• Device Lot Number: J6M2313X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2017
• Initial Date Received by Manufacturer: 06/27/2017
• Supplement Date Received by Manufacturer: 07/04/2017
• Initial Report FDA Received Date: 07/25/2017
• Supplement Report FDA Received Date: 08/03/2017
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 25 YR