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

Model Number	ONB11STF
Medical Device Problem Codes	Detachment Of Device Component (1104); Device Packaging Compromised (2916)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/08/2018
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, during a laparoscopic appendectomy, the device had a damaged seal on all ports.At the end of the surgery, they found a blue piece torn from the device that fell in the cavity of the patient.It was reported that a lot of time was wasted trying to find out if there were more pieces before they completed 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 obturator, circular seal; trocar and envelope seal appeared intact.Pmv performed functional testing; the device 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 conditions.If information is provided in the future, a supplemental report will be issued.
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 a laparoscopic appendectomy, every time the surgeon inserted long and sharp instruments, like scissors or dissectors, transparent foreign object from the upper seal falls to the cavity which was very disturbing from surgeon¿s view.That object would glare from scope light to distract surgeon operating view.It was reported that a lot of time was wasted trying to find out if there were more pieces to complete the case.There was no patient injury.

• Brand Name: VERSAPORT
• 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: 7519787
• Report Number: 9612501-2018-01001
• Device Sequence Number: 19214684
• Product Code: GCJ
• UDI-Device Identifier: 10884521181397
• UDI-Public: 10884521181397
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K130435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2018

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 Model Number: ONB11STF
• Device Catalogue Number: ONB11STF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Initial Date Received by Manufacturer: 05/09/2018
• Supplement Date Received by Manufacturer: 08/06/2018; 10/17/2018
• Initial Report FDA Received Date: 05/16/2018
• Supplement Report FDA Received Date: 08/22/2018; 11/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1