MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CORPORATION INTUITIVE 5MM CANNULA SEAL; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	400161
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/17/2017
Type of Reportable Event	Malfunction
Event or Problem Description
"a piece tore off and fell into the abdomen.It was removed and the entire item was removed from the field" the device is a 5mm cannula seal for a da vinci case, the size of the piece that fell into patient is approximately the size of a pencil led.

• Brand Name: INTUITIVE 5MM CANNULA SEAL
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES CORPORATION; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7103971
• Report Number: 7103971
• Device Sequence Number: 1934036
• Product Code: GCJ
• UDI-Device Identifier: 00607915119775
• UDI-Public: (01)00607915119775(17)190404(30)01(10)1267415
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 11/28/2017
• Report Date (Section F): 11/28/2017

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: 04/04/2019
• Device Model Number: 400161
• Device Catalogue Number: 400161
• Device Lot Number: 1267415
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 11/28/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2017
• Patient Sequence Number: 1
• Patient Age: 5 YR
• Date Report Sent to FDA: 11/28/2017