MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFS12, 11X100 KII SLEEVE ADVFIX 12/BX; GCJ

Model Number	CFS12
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return.A follow-up report will be provided upon the completion of the investigation.
Event or Problem Description
Procedure performed: laparoscopic nephrectomy.Event description: the tip of the cannula fractured and fragmented inside the patient during a lap nephrectomy case with [name].He is unaware of the exact point in the procedure when it fractured but noticed it around midway through, as he was mobilizing the kidney.The fragment was recovered from inside the patient and matched the defect on the cannula, there was no reported harm done to the patient.He noted that he usually uses the 12x100mm advanced fixation trocar however he used 11x100 z-thread as that is what was given to him during the procedure.Additional information received from applied team member via email on (b)(6) 2018: the surgeon seemed to think it was a threaded trocar but going back to the theatres to have a look at it, i noticed that it's definitely a 11x100 kii sleeve advanced fixation mod.Cfs12.Type of intervention: ni.Patient status: no patient injury or illness occurred associated with the complaint event.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with a green fragment.Visual inspection confirmed the complainant's experience of a fractured cannula tip.The fragment completed the missing portion on the cannula tip.Testing was performed on the event unit, and the balloon was found to be leaking.Based on the condition of the returned unit and the description of the event, it is likely that the cannula tip fracture was caused by force applied at the cannula tip by an instrument that was inserted through the trocar during the procedure.Engineering determined that the balloon leakage was caused by the damaged cannula tip.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 device and/or process enhancements intended to further minimize the potential for this type of event to occur.

• Brand Name: CFS12, 11X100 KII SLEEVE ADVFIX 12/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7347380
• Report Number: 2027111-2018-00110
• Device Sequence Number: 785487
• Product Code: GCJ
• UDI-Device Identifier: 00607915119850
• UDI-Public: (01)00607915119850(17)200420(30)01(10)1294928
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K083638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2018

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: Other
• Device Expiration Date: 04/20/2020
• Device Model Number: CFS12
• Device Catalogue Number: 101245401
• Device Lot Number: 1294928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2018
• Supplement Date Received by Manufacturer: 02/20/2018
• Initial Report FDA Received Date: 03/16/2018
• Supplement Report FDA Received Date: 04/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1