MAUDE Adverse Event Report: APPLIED MEDICAL CFB33, 11X100 KII SH BLD ADVFIX 6/BX; GCJ

Model Number	CFB33
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ra has received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.
Event or Problem Description
Vats - video assisted thoracoscopic surgery - "trocar was inserted and utilized during case.Upon removal of the trocar, it was determine that the tip had fractured." type of intervention - "area was inspected and reviewed by surgeon but remaining material could not be seen." patient status - "stable upon discharge from the operating room.".
Additional Manufacturer Narrative
Additional information received.Investigation summary: the event unit was returned for evaluation.Engineering confirmed that a piece at the tip of the cannula had broken off.During the manufacturing process, all trocars are 100% visually inspected prior to packaging.The root cause of the event is likely the result of external force applied on the cannula in combination with lipid exposure.Although the exact root cause could not be confirmed, 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.In accordance with 21 cfr 803.56, if additional information is obtained which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.
Event or Problem Description
Additional information obtained via email from customer on may 25, 2016: "the trove fractured at the tip.".

• Brand Name: CFB33, 11X100 KII SH BLD ADVFIX 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5668046
• Report Number: 2027111-2016-00390
• Device Sequence Number: 432207
• Product Code: GCJ
• UDI-Device Identifier: 00607915119843
• UDI-Public: (01)00607915119843(17)180817(30)01(10)1253197
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Expiration Date: 08/17/2018
• Device Model Number: CFB33
• Device Catalogue Number: 101246001
• Device Lot Number: 1253197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/19/2016
• Supplement Report FDA Received Date: 12/02/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other