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	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ra has received the incident device and the product has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of the investigation.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.
Event or Problem Description
Robotic radical prostatectomy: "the surgery was performed and the doctors saw that the pneumo was lost.The doctors reviewed the optical trocar (ctr71) was broken.The optical trocar (ctr71) was changed and the same thing happened." additional information received august 09, 2016: the lot number was the same for both incidents (first incident is (b)(6)), the trocars did not particulate when they broke, only a crack and no particulate was left in the patient.Type of intervention: "unknown." patient status: "unknown.".
Additional Manufacturer Narrative
Additional information was requested from the customer and provided.Investigation summary: the event unit was returned for evaluation.Upon inspection, engineering noted a crack in the cannula.Engineering noted that the cannula wall thickness did not meet specification.During the manufacturing process, all trocars are thoroughly inspected for functionality and performance prior to packaging.The crack in the cannula is likely the result of either excessive external force placed on the cannula during the robotic procedure in combination with the uneven wall thickness of the cannula.Although the exact root cause could not be confirmed, applied medical has opened a corrective and preventative action report to further elevate and track this investigation and implement appropriate corrective actions to mitigate this type of event.In accordance with 21 cfr 803.56, if additional information is obtained which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.

• 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: 5902098
• Report Number: 2027111-2016-00592
• Device Sequence Number: 18837719
• Product Code: GCJ
• UDI-Device Identifier: 00607915125042
• UDI-Public: (01)00607915125042(17)181018(30)01(10)21257443
• Combination Product (Y/N): N
• PMA/510(K) Number: K060096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2016

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: 10/18/2018
• Device Model Number: CTR71
• Device Catalogue Number: 101470675
• Device Lot Number: 1257443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2016
• Supplement Report FDA Received Date: 12/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1