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

Model Number	176674P
Medical Device Problem Codes	Failure to Cut (2587); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the optical trocar and lens were intact.The fixation trocar, circular and duckbill seal were received.The device was received inserted into the cannula.Functional testing found that the knife blade advanced and cut through the test media when the trigger was actuated, while the port failed an air leak test.It was reported that the knife blade was unexpectedly exposed before use, and the knife cut the tissue but it did not transect the tissue smoothly, creating a jagged line.The reported issues could not be confirmed.The most likely cause could not be established from the information available.Prolonged insertion can cause the duckbill seal to become stretched.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a laparoscopic excision of lesion of the uterus, the knife blade was exposed a little bit and did not cut smoothly.A new device was taken out and used according to the surgeon's judgement.There was no patient injury.

• 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: 10544323
• Report Number: 9612501-2020-01324
• Device Sequence Number: 19573694
• Product Code: GCJ
• UDI-Device Identifier: 10884521080652
• UDI-Public: 10884521080652
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2020

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: 09/30/2024
• Device Model Number: 176674P
• Device Catalogue Number: 176674P
• Device Lot Number: J9K3234Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 09/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1