MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTB71, KII 12X150MM SHLD BLD Z-THR, 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CTB71
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: robotic lap chole.Event description: rep was not in the case, but spoke to the doctor.Patient was morbidly obese.The trocar snapped in half while in the patient.The stress/ torque on the trocar seemed to cause the trocar to snap while they were attaching the robotic camera.The trocar snapped in 2 pieces.They extended the incision to remove the distal half of the trocar and then placed another trocar to complete the case.There was no particulation.There was not patient injury.There are no photos available.The device is available to be returned.Intervention: pieces were retrieved and trocar was replaced.Patient status: no injury to the patient.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience of a fractured cannula.Based on the condition of the returned unit, it is likely that the reported event was caused by uneven wall thickness, which occurred during the injection molding process of the cannula.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Applied medical continuously seeks to improve the form, function and ease of use of its products.As part of this process, applied medical has implemented process enhancements intended to further minimize the potential for this type of incident to occur.
Event or Problem Description
Procedure performed: robotic lap chole.Event description: rep was not in the case, but spoke to the doctor.Patient was morbidly obese.The trocar snapped in half while in the patient.The stress/ torque on the trocar seemed to cause the trocar to snap while they were attaching the robotic camera.The trocar snapped in 2 pieces.They extended the incision to remove the distal half of the trocar and then placed another trocar to complete the case.There was no particulation.There was not patient injury.There are no photos available.The device is available to be returned.Intervention: pieces were retrieved and trocar was replaced.Patient status: no injury to the patient.

• Brand Name: CTB71, KII 12X150MM SHLD BLD Z-THR, 6/BX
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8791724
• Report Number: 2027111-2019-00515
• Device Sequence Number: 2665744
• Product Code: GCJ
• UDI-Device Identifier: 00607915125066
• UDI-Public: (01)00607915125066(17)200405(30)01(10)1293502
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 08/28/2019

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: 04/05/2020
• Device Model Number: CTB71
• Device Catalogue Number: 101415501
• Device Lot Number: 1293502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 07/15/2019
• Supplement Report FDA Received Date: 08/28/2019
• 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: ROBOT, CAMERA