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

Model Number	ONBFCA12ST
Medical Device Problem Code	Device Packaging Compromised (2916)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, the incident sample has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: occurred during a laparoscopic rectosigmoidectomy procedure.The seal of the port was damaged.In order to resolve the issue and complete the case, opened a new 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 cut.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 conditions.Replication of the cut 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 rd; north haven CT 06743
• MDR Report Key: 6994467
• Report Number: 1219930-2017-08463
• Device Sequence Number: 1005752
• Product Code: GCJ
• UDI-Device Identifier: 10884521181328
• UDI-Public: 10884521181328
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K130435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• 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: 10/25/2017
• Supplement Date Received by Manufacturer: 08/04/2018
• Initial Report FDA Received Date: 11/01/2017
• 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