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)
Date of Event	04/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device has been returned for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: unknown.Incident description: at the end of the procedure when the user was removing the trocar from the abdomen the doctor noticed that the cannula cracked in the middle of the shaft.The user was able to remove all pieces of the trocar.Type of intervention: unknown.Patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Upon inspection, engineering was able to confirm the complainant's experience of a fractured cannula.Crack lines near the tip of the cannula were also observed.The wall thickness of the cannula was measured and was found to be uneven.The likely root cause of the fracture is the uneven cannula wall thickness, which occurred during the injection molding process of the cannula.The likely root cause of the cracking near the tip is likely due to lipid exposure, which could cause the part to be more prone to fractures.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 will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.

• 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: 6574270
• Report Number: 2027111-2017-01756
• Device Sequence Number: 18833687
• Product Code: GCJ
• UDI-Device Identifier: 00607915125042
• UDI-Public: (01)00607915125042(17)190831(30)01(10)1278524
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 05/30/2017

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: 08/31/2019
• Device Model Number: 2
• Device Catalogue Number: 2
• Device Lot Number: 1278524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/17/2017
• Supplement Report FDA Received Date: 05/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1