MAUDE Adverse Event Report: COVIDIEN LP VERSAPORT PLUS; LAPAROSCOPE, GENERAL PLASTIC SURGERY

Model Number	179078PF
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
While surgeon was putting in trocar with cannula, the pieces broke.All pieces were retrieved.Nothing was retained by the patient.The device was replaced, and the procedure was completed as planned with no harm to the patient.The device was saved and will be returned for failure analysis.Manufacturer response for laparoscope, general plastic surgery, versaport plus (per site reporter).The device will be returned for failure analysis.Any further correspondence will be shared as it is made available.

• Brand Name: VERSAPORT PLUS
• Common Device Name: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LP; 710 medtronic parkway; minneapolis MN 55432
• MDR Report Key: 8482100
• Report Number: 8482100
• Device Sequence Number: 19278528
• Product Code: GCJ
• UDI-Device Identifier: 20884521082684
• UDI-Public: (01)20884521082684
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2019
• Report Date (Section F): 03/05/2019

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: 179078PF
• Device Catalogue Number: 179078PF
• Device Lot Number: J8F1135X
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/04/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 97
• Date Report Sent to FDA: 03/05/2019