MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF71, 12X150 KII FIOS ADVFIX 6/BX; GCJ

Model Number	6
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ra has received the incident device and the product has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
Procedure performed: lap chole.Event description: trocar was being used for the camera port.At the end of case, scrub noticed a piece of cannula missing from tip.Type of intervention: looked and looked in patient but could not find it.Patient status: they said there was no initial injury to patient, but could not find piece.
Additional Manufacturer Narrative
Investigation summary: the event unit was returned to applied medical for evaluation with the balloon inflated.Upon inspection, engineering was able to confirm the complainant's experience of cannula tip fracture.The internal components inside the balloon insufflation port were also observed to be dislodged.Tested confirmed that the balloon was able to inflate and retain air.It is likely that the cannula tip fracture was caused by a combination of force applied on the cannula during the procedure and lipid exposure.The dislodgment of the internal components of the insufflation port is unrelated to the complainant's experience and was likely caused by an external force applied to the insufflation port by a syringe that was not provided with the product.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: CFF71, 12X150 KII FIOS ADVFIX 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6596114
• Report Number: 2027111-2017-01817
• Device Sequence Number: 10940914
• Product Code: GCJ
• UDI-Device Identifier: 00607915123048
• UDI-Public: (01)00607915123048(17)181103(30)01(10)1256739
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: 6
• 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): 06/16/2017

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: 11/03/2018
• Device Model Number: 6
• Device Catalogue Number: 6
• Device Lot Number: 1256739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2017
• Supplement Report FDA Received Date: 06/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1