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

Model Number	CFR71
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2017
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 cannula tip fracture.Engineering also observed a tear in the balloon.Based on the condition of the returned unit and the description of the event, it is likely that the reported event was caused by forces applied during the procedure in combination with lipid exposure of the tip of the cannula.The tear in the balloon was likely caused by contact with a sharp object or instrument.The probability and criticality of harm resulting from these failures 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.This report represents the combined initial and final.Based on the description of the event during initial intake of the complaint, the event was deemed not reportable.After evaluation by engineering, the event is deemed reportable due to the cannula tip fracture.
Event or Problem Description
Procedure performed: laparoscopic abdominal case.Event description: "the trocar broke while in patient's abdomen; the case was converted to open.No injury occurred to patient." type of intervention: "the case was converted to open." patient status: no patient injury or illness.

• Brand Name: CFR71, 12X150 KII OPT ADVFIX 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6966895
• Report Number: 2027111-2017-02074
• Device Sequence Number: 634016
• Product Code: GCJ
• UDI-Device Identifier: 00607915123031
• UDI-Public: (01)00607915123031(17)200502(30)01(10)1296100
• 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): 10/20/2017

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: Other
• Device Expiration Date: 05/02/2020
• Device Model Number: CFR71
• Device Catalogue Number: 101256201
• Device Lot Number: 1296100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2017
• Initial Report FDA Received Date: 10/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1