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

Model Number CTB03

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2018

Event Type  malfunction  

Manufacturer Narrative

No product is being returned for evaluation.A follow-up report will be provided upon completion of investigation.

Event Description

Procedure performed: lap chole event description: the surgeon initially went in with the hasson technique for the first port.The surgeon got the ctb03 trocar, activated it and placed the trocar.When the surgeon looked at the trocar from the first port with the camera the surgeon observed that the blade was still exposed.The surgeon took out the obturator and hit it against something hard to attempt to see if the shield would cover the blade; however, it did not work and the blade was still exposed.The surgeon continued to use the trocar for the 3rd port with the blade still exposed and completed the case without further incident.No other instruments were in use inside the trocar at the time of the event.No patient injury was reported.The device was discarded and is not available for return.The facility is currently undergoing a trocar product trial.The rep was not present for the case.Additional information was received via email on (b)(6) 2018 from account manager: "there was no injury or illness associated with the complaint event, and the patient status is fine.The trocar was replaced and the case proceeded as expected.I do not have any specific patient information." type of intervention: the surgeon took out the obturator and hit it against something hard to attempt to see if the shield would cover the blade; however, it did not work and the blade was still exposed.The surgeon continued to use the trocar for the 3rd port with the blade still exposed and completed the case without further incident."the trocar was replaced and the case proceeded as expected." patient status: no patient injury was reported."there was no injury or illness associated with the complaint event, and the patient status is fine.".

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and the complainant's experience could not be replicated or confirmed.In the absence of the event unit, it is difficult to determine the exact root cause of the event.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.

• Brand Name: CTB03, 5X100 KII SH BLD ZTHR 6/BX
• Type of Device: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7452324
• MDR Text Key: 107079440
• Report Number: 2027111-2018-00158
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915123512
• UDI-Public: (01)00607915123512(17)201210(30)01(10)1311866
• Combination Product (y/n): N
• PMA/PMN Number: K072674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/10/2020
• Device Model Number: CTB03
• Device Catalogue Number: 101138301
• Device Lot Number: 1311866
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/05/2018
• Patient Sequence Number: 1