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	08/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ra has received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of 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.There is no report of serious injury or death associated with this event.
Event or Problem Description
Robotic assisted lap chole- "trocar was used during first entry with laparoscope.As surgeon was placing second trocar he positioned the 12x150 down with scope to look at upper portion of abdominal wall to visualize second trocar placement.The 12x150 then snapped in half leaving a portion inside patient.The surgeon was able to retrieve the broken piece and patient was not injured." patient status- "patient was not injured.".
Additional Manufacturer Narrative
Investigation summary: the event unit was returned for evaluation and engineering confirmed the z-thread of the cannula was fractured.During the manufacturing process, all trocars are thoroughly inspected for functionality and performance prior to packaging.Although the root cause of the cracked cannula could not be confirmed, applied medical has opened a corrective and preventative action (capa) to further elevate and track this investigation and implement appropriate corrective actions to mitigate this type of event.In accordance to 21 cfr 803.56, if we obtain additional information, 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: 5947722
• Report Number: 2027111-2016-00628
• Device Sequence Number: 590100
• Product Code: GCJ
• UDI-Device Identifier: 00607915125042
• UDI-Public: (01)00607915125042(17)190316(30)01(10)1267292
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 12/08/2016

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: 03/16/2019
• Device Model Number: CTR71
• Device Catalogue Number: 101063601
• Device Lot Number: 1267292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2016
• Supplement Report FDA Received Date: 12/08/2016
• Patient Sequence Number: 1