MAUDE Adverse Event Report: COVIDIEN LLC VISIPORT PLUS; LAPAROSCOPE, GENERAL PLASTIC SURGERY

Model Number	176673PF
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/18/2018
Type of Reportable Event	Malfunction
Event or Problem Description
While inserting the visiport, surgeon noticed that a small piece of plastic had broken off of the port.It was on the drapes, removed and taken off of the field.Manufacturer response for laparoscope, general plastic surgery, visiport plus (per site reporter): unknown.
Event or Problem Description
While inserting the visiport, surgeon noticed that a small piece of plastic had broken off of the port.It was on the drapes, removed and taken off of the field.Manufacturer response for laparoscope, general plastic surgery, visiport plus (per site reporter), unknown.

• Brand Name: VISIPORT PLUS
• Common Device Name: LAPAROSCOPE, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 7568664
• Report Number: 7568664
• Device Sequence Number: 204738
• Product Code: GCJ
• UDI-Device Identifier: 10884521080645
• UDI-Public: (01)10884521080645
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2018
• Report Date (Section F): 05/30/2018

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: Physician
• Device Model Number: 176673PF
• Device Catalogue Number: 176673PF
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/30/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/05/2018
• Supplement Report FDA Received Date: 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Date Report Sent to FDA: 05/30/2018