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

Model Number	176674P
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/08/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter: occurred during a laparoscopic rectosigmoidectomy.During introduction of the port into the abdominal wall, a small piece of plastic was visible in the tip of the obturator after 'firing' one time.The piece of plastic was coming from the lens of the obturator.The lens disengaged from the device, but did not fall into the patient cavity.To complete the procedure, another trocar was used.No patient injury or extension in surgical time.Patient status 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 optical trocar, lens, fixation trocar, circular and envelop seals all appeared intact.The device was received inserted into the cannula, over insertion can cause the envelope seal to become stretched.Pmv performed functional testing: when the trigger was actuated, the knife blade advanced and cut through the test media.The trocar 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 component related failures.The packaging was received open by the account therefore we cannot reliably determine the condition of the device prior to use.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: 6845152
• Report Number: 9612501-2017-06080
• Device Sequence Number: 1522855
• Product Code: GCJ
• UDI-Device Identifier: 20884521080659
• UDI-Public: 20884521080659
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2017

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 Expiration Date: 09/30/2021
• Device Model Number: 176674P
• Device Catalogue Number: 176674P
• Device Lot Number: J6J0673X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2017
• Initial Date Received by Manufacturer: 08/08/2017
• Supplement Date Received by Manufacturer: 10/25/2017
• Initial Report FDA Received Date: 09/06/2017
• Supplement Report FDA Received Date: 11/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1