MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CNGL3, GELPOINT MINI ADV ACCESS PLATFORM; GCJ

Model Number	CNGL3
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Applied medical has just received the event device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: "robotic uso" event description: "pulling out pieces of omentum through the trocar.The seal came out of trocar." type of intervention: unknown.Patient status: "no patient injury.".
Additional Manufacturer Narrative
Investigation summary: the event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience of a dislodged shield, an internal component of the sleeve.Based on the condition of the returned unit, it is likely that the reported event was caused by the instrument used during the procedure or the tissue that was pulled through the sleeve.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.

• Brand Name: CNGL3, GELPOINT MINI ADV ACCESS PLATFORM
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7223466
• Report Number: 2027111-2018-00052
• Device Sequence Number: 2301264
• Product Code: GCJ
• UDI-Device Identifier: 00607915131784
• UDI-Public: (01)00607915131784(17)200904(30)01(10)1304080
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K090275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2018

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: Other
• Device Expiration Date: 09/04/2020
• Device Model Number: CNGL3
• Device Catalogue Number: 101361901
• Device Lot Number: 1304080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2017
• Supplement Date Received by Manufacturer: 12/28/2017
• Initial Report FDA Received Date: 01/26/2018
• Supplement Report FDA Received Date: 02/28/2018
• Patient Sequence Number: 1