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

Model Number	2
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned for evaluation but lot # is provided.A device history report is to be reviewed by engineering.A follow up report will be sent once the results have been analyzed.
Event or Problem Description
This (b)(4) will address the event device 1 of 2.(b)(4) will address the event device 2 of 2.Procedure performed - unknown."i need to bring to your attention that dr.[doctor's name] has had 2 different cases where the ctr71 trocar broke and pieces needed to be removed from the patient.The lot number from the trocar used in his case today is 1288495." additional information received via telephone from the territory manager on (b)(6)2017: it was noted during the surgery that gas was leaking and upon examining the trocar, a hair line crack was observed.The trocar was replaced with a new trocar and the surgery was completed without incident.Additional information received via email from the territory manager on (b)(6)2017: event device was "thrown away" and no patient injury occurred.Type of intervention: unknown.Patient status: no patient injury occurred.
Additional Manufacturer Narrative
The event product was not returned to applied medical for evaluation.In the absence of the subject device, it is difficult to determine the root cause of the event.The probability and criticality of harm resulting from this type of event 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 is currently researching possible process enhancements intended to further minimize the potential for this type of event to occur.

• 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: 6644180
• Report Number: 2027111-2017-01860
• Device Sequence Number: 13715451
• 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: PA
• Initial Reporter Country: US
• PMA/510(K) Number: 2
• 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): 06/29/2017

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: Other
• Device Expiration Date: 02/06/2020
• Device Model Number: 2
• Device Catalogue Number: 2
• Device Lot Number: 1288495
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/15/2017
• Supplement Report FDA Received Date: 06/29/2017
• Patient Sequence Number: 1