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	12/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device has been returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: "robotic inguinal hernia repair".Event description: "on (b)(6) 2017 at the end of a procedure, left inguinal hernia repair, approximately 45 minutes a valsalva maneuver was performed while removing the camera port and the port broke into two pieces.There was no injury to the patient." additional information was received via email from account manager on 12-nov-2017 at 1:38 pm "no patient injury.Physician was dr.[name] they had to get a new trocar for the 12 port." type of intervention: "they had to get a new trocar for the 12 port." patient status: "no patient injury".
Additional Manufacturer Narrative
The cannula of the event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience of 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 uneven wall thickness, which occurred during the injection molding process of the cannula.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 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.
Additional Manufacturer Narrative
This report is to follow up medwatch report #mw5075052.
Event or Problem Description
Additional information was received via mail from fda, mw5075052 on wednesday 28feb2018 "a 12x150mm camera port made by applied medical: during the removal of camera port a valsalva maneuver was performed and the port broke in half.No pieces were left in the patient and no 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: 7149258
• Report Number: 2027111-2017-02172
• Device Sequence Number: 1013342
• Product Code: GCJ
• UDI-Device Identifier: 00607915125066
• UDI-Public: (01)00607915125066(17)200209(30)01(10)1289388
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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,Followup
• Report Date (Section B): 03/05/2018

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: Other
• Device Expiration Date: 02/09/2020
• Device Model Number: CTB71
• Device Catalogue Number: 101415501
• Device Lot Number: 1289388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2017
• Supplement Date Received by Manufacturer: 12/07/2017; 12/07/2017
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 01/16/2018; 03/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1