MAUDE Adverse Event Report: APPLIED MEDICAL CTF01, 5X150 KII FIOS ZTHR 6/BX; GCJ

Model Number	CTF01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/23/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: the event unit was not returned for evaluation.In the absence of the subject device, it is difficult to determine the root cause of the incident.A review of the manufacturing records indicates this lot passed all manufacturing and quality inspections the exact root cause of this incident could not be determined, however, similar incidents in the past have shown that this incident may have been due to an interruption in the molding process.Applied medical has recently implemented process enhancements intended to minimize the potential for this type of incident to occur during the manufacturing process.In accordance to 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.
Event or Problem Description
Laparoscopic roux-en-y "surgeon was placing trocar in abdomen and torked just enough to snap plastic trocar." patient status- normal post op.

• Brand Name: CTF01, 5X150 KII FIOS ZTHR 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5387149
• Report Number: 2027111-2016-00087
• Device Sequence Number: 18965943
• Product Code: GCJ
• UDI-Device Identifier: 00607915124014
• UDI-Public: (01)00607915124014(17)180107(30)01(10)1237963
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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
• Report Date (Section B): 01/22/2015

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: 01/07/2018
• Device Model Number: CTF01
• Device Catalogue Number: 101061001
• Device Lot Number: 1237963
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1