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

Model Number 400161

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/17/2017

Event Type  malfunction  

Event 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
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES CORPORATION; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7103971
• MDR Text Key: 94410696
• Report Number: 7103971
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915119775
• UDI-Public: (01)00607915119775(17)190404(30)01(10)1267415
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/04/2019
• Device Model Number: 400161
• Device Catalogue Number: 400161
• Device Lot Number: 1267415
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/28/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 11/28/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 5 YR