MAUDE Adverse Event Report: APPLIED MEDICAL CTF12, 5X100 KII FIOS ZTHR DP 10/BX; GCJ

Model Number	CTF12
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device is anticipated to return.A follow-up report will be provided upon completion of the 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
Lap chole - "surgeon was using direct vision to gain access/place one of the ports and the tip broke off of the obturator during this action." type of intervention: "the broken tip was found and recovered." patient status - "they didn't express further concern after the procedure.".
Additional Manufacturer Narrative
Additional information was requested from the customer but was not provided.Investigation summary: the obturator of the event unit was returned for evaluation along with one of the broken pieces of the fios® tip.Upon inspection, engineering confirmed the tip of the obturator was broken off from the shaft.During the manufacturing process, all trocars are thoroughly inspected and tested for functionality and performance prior to packaging.Although the exact root cause of this event could not be confirmed, the engineering evaluation revealed that the likely root cause may be due to manufacturing.Applied medical continuously seeks to improve the form, function, and ease of use of its products.As part of this continuous process, applied medical is researching process enhancements intended to minimize the potential for this type of incident to occur.In accordance with 21 cfr 803.56, if we obtain additional information, which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.

• Brand Name: CTF12, 5X100 KII FIOS ZTHR DP 10/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5575032
• Report Number: 2027111-2016-00307
• Device Sequence Number: 10806888
• Product Code: GCJ
• UDI-Device Identifier: 00607915125707
• UDI-Public: (01)00607915125707(17)180930(30)01(10)1255845
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K041795
• 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): 04/13/2016

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 09/30/2018
• Device Model Number: CTF12
• Device Catalogue Number: 101062401
• Device Lot Number: 1255845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/13/2016
• Supplement Report FDA Received Date: 11/15/2016
• 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: Required Intervention