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

Model Number	176674P
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, when inserting the trocar during a laparoscopic bariatric surgery, no matter how many times the surgeon pulled the trigger, there was no feeling that the tissue fiber was cut well, and the trocar could not be inserted.Another device was used to complete the case.There was no patient 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 and lens appeared intact.The optical trocar was received inserted into the cannula, prolonged insertion can cause the seals to become stretched.The optical trocar was removed and the seals were observed to be stretched.A functional evaluation found that when the trigger was actuated, the knife blade advanced and cut through the test media.The port 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.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.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 18750 ; DO 18750
• MDR Report Key: 8444570
• Report Number: 9612501-2019-00569
• Device Sequence Number: 344988
• 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,Followup
• Report Date (Section B): 05/08/2019

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: 05/31/2023
• Device Model Number: 176674P
• Device Catalogue Number: 176674P
• Device Lot Number: J8E2532X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Initial Date Received by Manufacturer: 02/27/2019
• Supplement Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 05/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1