MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTB71, KII 12X150MM SHLD BLD Z-THR, 6/BX; GCJ

Model Number	CTB71
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit has been returned to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: robotic cystectomy.Event description: they completed a robotic cystectomy case.They went in with an applied trocar and they put the 8mm robotic davinci inside the applied trocar, followed by the camera.While looking around inside the patient's body, they saw the trocar cannula in the patient.They did not realize that the cannula had broke.It was a clean break and no fragments.They were able to retrieve the cannula piece from the patient's body.They completed the case by using the [non-applied] trocar.They did not hook up the arm to the cannula at the time of incident.The break occurred along the shaft of the trocar.Type of intervention: they replaced the device with a [non-applied] trocar.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection of the event unit confirmed the complainant's experience of a fractured cannula.Based on the condition of the returned unit and the description of the event, it is likely that the reported event was caused by a combination of uneven wall thickness of the cannula of the event unit and the insertion of the da vinci trocar into the applied medical trocar.Applied medical trocars are not intended to be used with another trocar placed inside of it.The probability and criticality of harm resulting from this failure mode has been evaluated and were found to be at an acceptable level.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.Applied medical will reach out to the complainant with the results of the investigation.
Event or Problem Description
Procedure performed: robotic cystectomy.Event description: they completed a robotic cystectomy case.They went in with an applied trocar and they put the 8mm robotic davinci inside the applied trocar, followed by the camera.While looking around inside the patient's body, they saw the trocar cannula in the patient.They did not realize that the cannula had broke.It was a clean break and no fragments.They were able to retrieve the cannula piece from the patient's body.They completed the case by using the [non-applied] trocar.They did not hook up the arm to the cannula at the time of incident.The break occurred along the shaft of the trocar.Type of intervention: they replaced the device with a [non-applied] trocar.Patient status: no patient injury.

• Brand Name: CTB71, KII 12X150MM SHLD BLD Z-THR, 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8371224
• Report Number: 2027111-2019-00355
• Device Sequence Number: 1203977
• Product Code: GCJ
• UDI-Device Identifier: 00607915125066
• UDI-Public: (01)00607915125066(17)210211(30)01(10)1316459
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Initial,Followup
• Report Date (Section B): 04/05/2019

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: Health Professional
• Device Expiration Date: 02/11/2021
• Device Model Number: CTB71
• Device Catalogue Number: 101415501
• Device Lot Number: 1316459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/05/2019
• Supplement Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 02/26/2019
• Supplement Report FDA Received Date: 04/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CAMERA, DAVINCI