MAUDE Adverse Event Report: APPLIED MEDICAL CTS02, 5X100 KII SLEEVE ZTHR 12/BX; GCJ

Model Number	CTS02
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/17/2015
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.This report is to follow-up to medwatch report# (b)(4).
Event or Problem Description
"while placing disposable 5mm laparoscopic trocar in the patient the trocar cracked and had to be retrieved from the patient.The trocar and broken piece was retrieved from patient.Device usage problem: device failed (e.G.Broke, couldn't get it to work or stopped working)." patient status unknown.
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.(b)(4).
Event or Problem Description
"while placing disposable 5mm laparoscopic trocar in the patient the trocar cracked and had to be retrieved from the patient.The trocar and broken piece was retrieved from patient.Device usage problem: device failed (e.G.Broke, couldn't get it to work or stopped working)." patient status unknown.
Additional Manufacturer Narrative
Additional information was requested and was not provided.The incident product 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.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.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.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.This report is to follow-up to medwatch report# (b)(4).

• Brand Name: CTS02, 5X100 KII SLEEVE ZTHR 12/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 5471583
• Report Number: 2027111-2016-00173
• Device Sequence Number: 796653
• Product Code: GCJ
• UDI-Device Identifier: 00607915123499
• UDI-Public: (01)00607915123499(17)180519(30)01(10)1247323
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 02/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 05/19/2018
• Device Model Number: CTS02
• Device Catalogue Number: 101208701
• Device Lot Number: 1247323
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/01/2016
• Supplement Report FDA Received Date: 03/01/2016; 09/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1