MAUDE Adverse Event Report: APPLIED MEDICAL CTR21, 5X55 KII LP OPT ZTHR 6/BX; GCJ

Model Number	CTR21
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is to follow up with medwatch # (b)(4).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
Thorascopic excision of right pulmonary sequestration and primary repair of congenital diaphragmatic hernia - "applied medical trocar #ctr21 inserted without problem but broke when grasper was inserted into it for use.Tip of trocar broke off and had to be retrieved.All broken parts were accounted for; dr.Examined area with laparoscope after incident." patient status - unknown.
Additional Manufacturer Narrative
The event product was not returned to applied medical for evaluation.In the absence of the subject device, it is difficult to determine the root cause of the event.A review of the manufacturing records indicates this lot passed all manufacturing and quality inspections.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 report to further elevate and track this investigation and implement appropriate corrective actions to mitigate this type of event.This report is to follow up with medwatch# (b)(4).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: CTR21, 5X55 KII LP OPT ZTHR 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5668528
• Report Number: 2027111-2016-00363
• Device Sequence Number: 16218025
• Product Code: GCJ
• UDI-Device Identifier: 00607915126476
• UDI-Public: (01)00607915126476(17)180512(30)01(10)1245197
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 12/05/2016

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: 05/12/2018
• Device Model Number: CTR21
• Device Catalogue Number: 101179801
• Device Lot Number: 1245197
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/19/2016
• Supplement Report FDA Received Date: 12/05/2016
• 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