MAUDE Adverse Event Report: AMR 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	06/21/2016
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 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 - "end of case when the doctor was pulling out the trocar, she pulled it out and noticed that the cannula was broken.The rest of it was jutting out of the patient.She took a hemostat and pulled the rest of the cannula out.One piece had completely separated from the other.Clean break, nothing fell into the patient.Comment from rep: "larger patient probably a lot of torquing." patient status- no patient injury.
Additional Manufacturer Narrative
Correction - model# ctf01, 5x150 kii fios zthr 6/bx.
Additional Manufacturer Narrative
The event product was returned to applied medical for evaluation.Upon inspection, engineering confirmed the complainant's experience of a fractured cannula.The likely root cause of the fractured cannula is due to material degradation during the molding process, which could cause the part to be more prone to brittle fractures.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 process enhancements intended to further minimize the potential for this type of event to occur.

• Brand Name: CTF01, 5X150 KII FIOS ZTHR 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): AMR; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5804538
• Report Number: 2027111-2016-00527
• Device Sequence Number: 16193221
• Product Code: GCJ
• UDI-Device Identifier: 00607915124014
• UDI-Public: (01)00607915124014(17)171019(30)01(10)1233191
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K060096
• 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,Followup
• Report Date (Section B): 05/10/2017

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: 10/19/2017
• Device Model Number: CTF01
• Device Catalogue Number: 101061001
• Device Lot Number: 1233191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/19/2016
• Supplement Report FDA Received Date: 07/20/2016; 05/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1