MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF03, 5X100 KII FIOS ADVFIX 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CFF03
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/30/2019
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 bent trocar.The obturator was also cracked and fractured.The wall thickness of the cannula was measured and was found to be out of specification.Based on the condition of the returned unit and the event description, it is possible that the bent cannula was caused by the cannula wall thickness that was found to be out of specification, which could potentially cause the cannula to be more susceptible to bending during insertion.It is also possible that a high insertion force was applied to the trocar during insertion.It is possible that the obturator cracked and fractured due to a material abnormality or prolonged lipid exposure while the unit was in transit; however, the exact root cause could not be determined.The probability and criticality of harm resulting from this failure mode has been evaluated and were found to be at an acceptable level.A bent trocar is considered not reportable as it is unlikely to cause or contribute to death or serious injury.The event is being reported due to the fracture that was observed on the obturator during evaluation of the returned unit.
Event or Problem Description
Procedure performed: gastric sleeve.Event description: the rep was present for the case.Two trocars had been placed and pneumo established.It was mentioned that the peritoneum was tough to get through even with force.The pa was inserting the third trocar and was having to twist a little more than usual when the cannula and obturator bent at a 90 degree angle.The bend was about 3/4 of the way up the trocar.Pulled another cff03 to use in the case.Picture is attached.The device is available for return.Intervention: opened another cff03 to use in the case.Patient status: no patient injury.

• Brand Name: CFF03, 5X100 KII FIOS ADVFIX 6/BX
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 9782805
• Report Number: 2027111-2020-00402
• Device Sequence Number: 618539
• Product Code: GCJ
• UDI-Device Identifier: 00607915117641
• UDI-Public: (01)00607915117641(17)221107(30)01(10)1373114
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 03/03/2020

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: 11/07/2022
• Device Model Number: CFF03
• Device Catalogue Number: 101221001
• Device Lot Number: 1373114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1