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

Model Number	176673PF
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/27/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Md was placing the visiport trocar in patient.When md entered the abdomen and retracted the trocar, it was noted that the trocar was missing pieces and shattered in the patient.Team began searching for the pieces and eventually were able to locate the broken pieces.

• Brand Name: VISIPORT PLUS
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 7118520
• Report Number: 7118520
• Device Sequence Number: 11032839
• Product Code: GCJ
• UDI-Device Identifier: 10884521080645
• UDI-Public: (01)10884521080645((17)220731(10)J7G2585X
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 12/01/2017
• Report Date (Section F): 12/01/2017

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: Physician
• Device Expiration Date: 07/31/2022
• Device Model Number: 176673PF
• Device Catalogue Number: 176673PF
• Device Lot Number: J7G2585X
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/01/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Date Report Sent to FDA: 12/01/2017