MAUDE Adverse Event Report: APPLIED MEDICAL CTB03, 5X100 KII SH BLD ZTHR 6/BX; GCJ

Model Number	CTB03
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/30/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned for evaluation but lot # is provided.A device history report is to be reviewed by engineering.A follow-up report will be sent once the results have been analyzed.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
Procedure performed unknown."the surgeon was using the trocar by putting an instrument through the port and heard the trocar crack.They had to remove trocar and find all pieces in the patient." patient status - "released.".
Additional Manufacturer Narrative
Investigation summary: the event unit was not returned for evaluation, however, pictures of the unit were provided.Upon inspection of the pictures, engineering confirmed the tip of the cannula was fractured and noted the fracture appeared to be a clean break.A review of the manufacturing records indicates this lot passed all manufacturing and quality inspections.Although the exact root cause of the incident could not be determined, applied medical has received reports of similar issues and has opened a corrective and preventative action report to further elevate and track this investigation and implement appropriate corrective actions to mitigate this type of incident.Additional information was requested from the customer and provided.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.

• Brand Name: CTB03, 5X100 KII SH BLD ZTHR 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5390048
• Report Number: 2027111-2016-00061
• Device Sequence Number: 18955743
• Product Code: GCJ
• UDI-Device Identifier: 00607915123512
• UDI-Public: (01)00607915123512(17)180922(30)01(10)1254676
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K072674
• 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: Followup
• Report Date (Section B): 12/31/2015

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: 09/22/2018
• Device Model Number: CTB03
• Device Catalogue Number: 101138301
• Device Lot Number: 1254676
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/25/2016
• Supplement Report FDA Received Date: 07/27/2016
• 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