MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFR73, 12X100 KII OPT ADVFIX 6/BX; GCJ

Model Number	CFR73
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event product was returned to applied medical for evaluation.Upon inspection, engineering confirmed the complainant's experience of a cannula tip fracture.Engineering also noted a tear on the balloon.Based on the condition of the returned unit, it is likely that the cannula tip fracture was caused by the force applied on the unit in combination with lipid exposure.The likely root cause of the torn balloon is due to damage from instrument.The instructions for use states, "do not allow sharp instruments or objects to come into contact with the balloon." the probability and criticality of harm resulting from these failure modes 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 initial and final report.
Event or Problem Description
Procedure performed: "esophageal cancer surgery." event description: "when they want to finished the surgery, and then found the tip was broken.Surgeons pick up fragments from patient.Please see the attachment." type of intervention: unk.Patient status: "fine.".

• Brand Name: CFR73, 12X100 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: 6866908
• Report Number: 2027111-2017-01973
• Device Sequence Number: 699853
• Product Code: GCJ
• UDI-Device Identifier: 00607915119898
• UDI-Public: (01)00607915119898(17)200405(30)01(10)1293727
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K083638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/14/2017

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: 04/05/2020
• Device Model Number: CFR73
• Device Catalogue Number: 101245601
• Device Lot Number: 1293727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2017
• Initial Report FDA Received Date: 09/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1