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	09/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device returned has been returned for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: "retroperitoneoscopic left adrenalectomy" event description: "staff nurse in the or at the queens said an 11 mm x 100 mm had fragments of plastic that broke off the tip of the cannula.They had to retrieve at least 2 pieces and believe that they retrieved it." additional information was received via email from senior territory manager on wednesday 20-sep-2017 at 12:53 am: "the product id is kii fios fixation 11 x 100 mm, will try and find packing tomorrow.Will try to get the lot #.Instruments that were passed thru the trocar it was also used as a scope port.The name of the procedure is retro peritoneal adrenalectomy.This was a non-robotic procedure.The method of insertion was a partial cut down between the ribs, placed on an angle.Changed cannula, pieces of the broken cannula was retrieved." additional information was received via email from senior territory manager on wednesday 27-sep-2017 at 8:49 am: "she was inserting the trocar at a 30 degree angle between ribs.The surgeon's name was dr.[name].The trocar was being used as a working port, not a scope port.2 small pieces that were broken off from trocar sleeve retrieved and saved." type of intervention: "changed cannula." patient status: "no patient injury.".
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience of cannula tip fracture.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 probability and criticality of harm resulting from this failure 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.

• 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: 6941170
• Report Number: 2027111-2017-02057
• Device Sequence Number: 19050768
• Product Code: GCJ
• UDI-Device Identifier: 00607915119850
• UDI-Public: (01)00607915119850(17)190112(30)01(10)1262073
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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,Followup
• Report Date (Section B): 10/19/2017

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: 01/12/2019
• Device Model Number: CFS12
• Device Catalogue Number: 101245401
• Device Lot Number: 1262073
• 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: 09/18/2017
• Supplement Date Received by Manufacturer: 09/18/2017
• Initial Report FDA Received Date: 10/11/2017
• Supplement Report FDA Received Date: 10/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1