MAUDE Adverse Event Report: COVIDIEN LP LLC NORETH HAVEN VERSAPORT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	177798
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/22/2018
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, the cannula part of the trocar, was already damaged when it was unpacked from the original package.There was no patient involved.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one photograph of the device.The photograph depicts a gouge on the threaded cannula.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.Should new information become available, the file will be re-opened, and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) received one photograph.The photograph depicts a gouge on the threaded cannula.The visual inspection of the returned product noted that there was gouges on the threaded cannula.The condition in which the device was received precludes functional testing.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 gouges on the threads of the cannula 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 LP LLC NORETH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7419471
• Report Number: 1219930-2018-01978
• Device Sequence Number: 1097196
• Product Code: GCJ
• UDI-Device Identifier: 10884521134553
• UDI-Public: 10884521134553
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K963115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/12/2018

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: 177798
• Device Catalogue Number: 177798
• Device Lot Number: N7B0558X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Initial Date Received by Manufacturer: 03/26/2018
• Supplement Date Received by Manufacturer: 04/25/2018; 08/23/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 05/02/2018; 09/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1