MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTR33, 11X100 KII OPT ZTHR 6/BX; GCJ

Model Number	CTR33
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience of a damaged cannula tip.Based on the condition of the returned unit and the event description, it is likely that the reported event was caused by contact with an energy instrument that was inserted through the trocar during the procedure.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.This report is the combined initial and final report.
Event or Problem Description
Procedure performed: salpingectomy for ectopic pregnancy.Event description: "it was reported that this was a high bmi case with a small working space.Insufflation was fluctuating.Trocar was slightly inside the patient and a [energy instrument] was inside the trocar firing.The trocar melted.Once the issue was discovered the trocar was inspected for any fragmentation.The room confirmed nothing was left in the patient and since the case was 95% completed we finished the case and removed the trocar as soon as possible." type of intervention: "since the case was 95% completed we finished the case and removed the trocar as soon as possible." patient status: fine.

• Brand Name: CTR33, 11X100 KII OPT ZTHR 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7195257
• Report Number: 2027111-2018-00018
• Device Sequence Number: 13925238
• Product Code: GCJ
• UDI-Device Identifier: 00607915124236
• UDI-Public: (01)00607915124236(17)200913(30)01(10)1304794
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 01/16/2018

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: Health Professional
• Device Expiration Date: 09/13/2020
• Device Model Number: CTR33
• Device Catalogue Number: 101219801
• Device Lot Number: 1304794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2017
• Initial Report FDA Received Date: 01/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1