MAUDE Adverse Event Report: COVIDIEN NORTH HAVEN - MFG VERSAPORT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	ONBFCA12ST
Medical Device Problem Codes	Difficult to Insert (1316); Device Packaging Compromised (2916)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/24/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter: occurred during a laparoscopic procedure.The trocar seal broke at the clipper's introduction.The seal was damaged for both devices.In order to resolve the issue and complete the case, opened a new trocar and cannula.There was no patient harm.The patient outcome 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 that the circular seal was partially disengaged.The trocar, cannula 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 failures.Replication of the partially disengaged circular seal may occur when mishandled during clinical application.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VERSAPORT
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN NORTH HAVEN - MFG; 195 mcdermott road; north haven CT 06473
• MDR Report Key: 6821160
• Report Number: 1219930-2017-06703
• Device Sequence Number: 13463946
• Product Code: GCJ
• UDI-Device Identifier: 10884521181328
• UDI-Public: 10884521181328
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 08/22/2018

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 Expiration Date: 11/30/2020
• Device Model Number: ONBFCA12ST
• Device Catalogue Number: ONBFCA12ST
• Device Lot Number: N5L0164X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Initial Date Received by Manufacturer: 07/26/2017
• Supplement Date Received by Manufacturer: 08/04/2018
• Initial Report FDA Received Date: 08/25/2017
• Supplement Report FDA Received Date: 08/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1