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

Model Number	171313
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: post market vigilance received one device.The visual inspection of the device noted that the circular seal had a cut.The obturator, insufflation port and tube appeared intact.The condition of the device 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.Replication of the cut in the 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.Based on the evidence available the reported condition was confirmed.The file will be closed as sharp contact.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.
Event or Problem Description
According to the reporter, after inserting the device into the patient's abdominal cavity, abdominal air was leaking.No patient injury.

• Brand Name: MINI PORT
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN NORTH HAVEN-MFG; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7121754
• Report Number: 1219930-2017-09978
• Device Sequence Number: 1288032
• Product Code: GCJ
• UDI-Device Identifier: 10884521066298
• UDI-Public: 10884521066298
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K862611
• 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
• Report Date (Section B): 12/15/2017

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: 04/30/2022
• Device Model Number: 171313
• Device Catalogue Number: 171313
• Device Lot Number: N7D0562X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 12/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1