MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFR71, 12X150 KII OPT ADVFIX 6BX; GCJ

Model Number	CFR71
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience of a cannula tip fracture.Based on the condition of the returned unit and the description of the event, it is likely that the tip fracture was caused by a force exerted on the unit during the procedure.The probability and criticality of harm resulting from this failure mode have been evaluated and were found to be at an acceptable level.Applied medical continuously seeks to improve the form, function and ease of use of its products.As part of this process, applied medical is currently researching possible material/process enhancements intended to further minimize the potential for this type of event to occur.
Event or Problem Description
Procedure performed: unknown.Event description: the trocar broke while in the patient while connected to the robot as the camera port.1 piece broke off in the patient.It was retrieved and no patient injury occurred.It broke on removal.It was the cannula that broke.Unknown if it was a tip breakage.The case was finished at this time so no replacement was necessary.Type of intervention: the case was finished at this time so no replacement was necessary.Patient status: no patient injury.

• Brand Name: CFR71, 12X150 KII OPT ADVFIX 6BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7945456
• Report Number: 2027111-2018-00273
• Device Sequence Number: 1355850
• Product Code: GCJ
• UDI-Device Identifier: 00607915123031
• UDI-Public: (01)00607915123031(17)210312(30)01(10)1319668
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K083638
• 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
• Report Date (Section B): 10/08/2018

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: Health Professional
• Device Expiration Date: 03/12/2021
• Device Model Number: CFR71
• Device Catalogue Number: 101256201
• Device Lot Number: 1319668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 10/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1