MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTR71, KII 12X150 Z-THR OPT SEP SYS 6/BX; GCJ

Model Number	CTR71
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2017
Type of Reportable Event	Malfunction
Additional 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 confirmed.In the absence of the event unit, it is difficult to determine the root cause of the event.However, based on 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 seeks to improve the form, function, and ease of use of its products.As part of this process, applied medical has recently implemented process enhancements to further minimize the potential for this type of event to occur.This represents the initial and final report.This report is to follow-up medwatch (b)(4).
Event or Problem Description
Procedure performed: robotic rp/nodes/asr event description: medwatch (b)(4) was received via mail on 23aug2017 the patient was having surgery for a robotic rp/nodes/asr.The surgical tech removed the robot camera from the obturator/ trocar to clean it, before he attempted to reinsert the camera, the outer cannula snapped in half, leaving a portion still in the patient and half attached to the robot arm.They were able to remove it from the abdomen carefully using a hemostat.The obturator was inspected and appeared to be a clean break with no sharp edges or loose pieced.Patient was discharged home (b)(6) 2017.Additional information was received via email from clinical development, on 5-sep-2017 at 4:25 pm "it was just the cannula." type of intervention: unk.Patient status: "patient was discharged home on (b)(6) 2017".

• Brand Name: CTR71, KII 12X150 Z-THR OPT SEP SYS 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6881329
• Report Number: 2027111-2017-01986
• Device Sequence Number: 1183251
• Product Code: GCJ
• UDI-Device Identifier: 00607915125042
• UDI-Public: (01)00607915125042(17)200206(30)01(10)1288495
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K060096
• 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
• Report Date (Section B): 09/20/2017

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: 02/06/2020
• Device Model Number: CTR71
• Device Catalogue Number: 101470675
• Device Lot Number: 1288495
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2017
• Initial Report FDA Received Date: 09/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66