MAUDE Adverse Event Report: APPLIED MEDICAL CTR03, 5X100 KII OPT ZTHR 6/BX; GCJ

Model Number	CTR03
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/28/2016
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.There is no report of serious injury or death associated with this event.
Event or Problem Description
Procedure performed unknown- "report from the sales rep - during a process to drain, while passing a tube from the event unit to another trocar, the distal edge of the cannula was fractured despite giving no excessive power to the cannula.The fragment of the cannula was disposed by the facility." additional information received july 19, 2016: the incident happened at the end of the operation, during installation of drainage procedure, while passing a tube from the event unit to another trocar or vice versa.Patient status: no patient injury.
Additional Manufacturer Narrative
Investigation summary: the event unit was returned for evaluation.Upon inspection, engineering confirmed the tip of the cannula was fractured.The cannula wall thickness was measured and was within specification.During the manufacturing process, all trocars are thoroughly inspected for functionality and performance prior to packaging.Applied medical has opened a corrective and preventative action (capa) to further elevate and track this investigation and implement appropriate corrective actions to mitigate this type of event.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.

• Brand Name: CTR03, 5X100 KII OPT ZTHR 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5870221
• Report Number: 2027111-2016-00575
• Device Sequence Number: 416913
• Product Code: GCJ
• UDI-Device Identifier: 00607915123482
• UDI-Public: (01)00607915123482(17)180729(30)01(10)1252120
• Combination Product (Y/N): N
• PMA/510(K) Number: K060096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2016

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: 07/29/2018
• Device Model Number: CTR03
• Device Catalogue Number: 101290101
• Device Lot Number: 1252120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/11/2016
• Supplement Report FDA Received Date: 12/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1