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	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: laparoscopic esophagectomy.Event description: " this is a complaint from the market.(b)(4).Please refer to the complaint sheet for investigation.Sleeve damaged report from the sales rep laparoscopic esophagectomy procedure was preformed.The trocar was used as camera port.During removing the trocar from the patient, the distal end of the cannula was fragmented around two to three increments of the thread design part from the distal.The distance between ribs was narrower than general patient's.Other than that, the procedure had no anomaly such as applying an excessive force to the trocar in the customer's technique.The customer was unaware of the detail about when the incident occurred.Fragments fell off inside abdominal cavity, but they were removed from the patient.No injury and less bleeding.Initial investigation report by [distributor]: the event unit was returned to [distributor] and visually inspected.The threading part of the cannula was fragmented(fig.1).The three fragments were returned(fig.2).The sizes are respectively approx.9.0 mm x 4.0 mm, 4.0 mm x 2.0, 2.0 mm x 1.0 mm.Three fragments matched the missing locations on the sleeve in shape.However, we still noted a missing location on the sleeve.The fragments for the missing location were not returned to us.The unit will be returned to amr for further evaluation.(b)(4)." type of intervention: unknown.Patient status: "the patient status is ok now.".
Additional Manufacturer Narrative
The cannula of the event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience of a fractured cannula.Based on the condition of the returned unit, it is likely that the reported event was caused by lipid exposure, which could cause the cannula to be more prone to fractures.The probability and criticality of harm resulting from this failure 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: 6824759
• Report Number: 2027111-2017-01955
• Device Sequence Number: 851794
• Product Code: GCJ
• UDI-Device Identifier: 00607915125042
• UDI-Public: (01)00607915125042(17)190810(30)01(10)1276913
• 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): 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: Other
• Device Expiration Date: 08/10/2019
• Device Model Number: CTR71
• Device Catalogue Number: 101063601
• Device Lot Number: 1276913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2017
• Supplement Date Received by Manufacturer: 08/01/2017
• Initial Report FDA Received Date: 08/28/2017
• Supplement 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