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

Model Number	CTB71
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection observed that the shield, a clear plastic internal component of the seal, had dislodged from its original position.Testing was performed on the event unit, which confirmed the reported event of increased drag force.Based on the condition of the returned unit and the description of the event, it is likely that the shield was dislodged by a large instrument that was inserted through the seal.This would cause a larger portion of the septum, a rubber component of the seal, to make contact with instruments passing through the seal.The probability and criticality of harm resulting from this failure mode have 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.
Event or Problem Description
Procedure performed: robot prostatectomy.Intraoperatively, appearance of an inability to mobilize the arm holding the camera properly, the surgeon must exert abnormally strong pressure to push the camera into the patient's abdomen in order to have deep visibility.Discovery of the joint of the trocar that slides together with the camera, preventing it from stabilizing.Impossibility of placing the camera without the rebound effect.Actions undertaken: change of obese trocar 12mm x 150 required to continue the procedure.Hotline service of the robot has been called (ultimately not concerned with the problem).Consequences: other.If other: elongation of the operating time of 15 minutes.Type of intervention: change of obese trocar 12mm x 150 required to continue the procedure.Patient status: no patient injury or illness occur associated with the complaint event.

• 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: 8116520
• Report Number: 2027111-2018-00446
• Device Sequence Number: 295638
• Product Code: GCJ
• UDI-Device Identifier: 00607915125066
• UDI-Public: (01)00607915125066(17)201219(30)01(10)1312938
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K072674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/29/2018

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: 12/20/2017
• Device Model Number: CTB71
• Device Catalogue Number: 101415501
• Device Lot Number: 1312938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2018
• Initial Report FDA Received Date: 11/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1