MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTS02, 5X100 KII SLEEVE ZTHR 12/BX; GCJ

Model Number	CTS02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and the complainant's experience could not be replicated or confirmed.In the absence of the event unit, it is difficult to determine the exact root cause of the event.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 follow-up medwatch report #"450040-2018-008".This report represents the initial and final report.
Event or Problem Description
Procedure performed: laproscopic tubal.Event description: medwatch report #"450040-2018-008" was received via mail on 26 jun 2018: "describe the event or problem: reported from the or that tip of kii sleeve trochar 5 x 100mm broke off in patient's abdomen during laproscopic tubal.The surgeon was unable to locate the broken tip in the abdomen by visual searching or after an abdominal x-ray.It was determined to close the patient after unsuccessful thorough attempts to find the missing piece of the trochar tip." additional information received via email on (b)(6) 2018 from risk manager: "the patient was discharged stable." type of intervention: "the surgeon was unable to locate the broken tip in the abdomen by visual searching or after an abdominal x-ray.It was determined to close the patient after unsuccessful thorough attempts to find the missing piece of the trochar tip." patient status: "the patient was discharged stable.".

• Brand Name: CTS02, 5X100 KII SLEEVE ZTHR 12/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7708289
• Report Number: 2027111-2018-00234
• Device Sequence Number: 16340987
• Product Code: GCJ
• UDI-Device Identifier: 00607915123499
• UDI-Public: (01)00607915123499(17)210129(30)01(10)1315929
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/20/2018

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: 01/29/2021
• Device Model Number: CTS02
• Device Catalogue Number: 101208701
• Device Lot Number: 1315929
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 07/20/2018
• Patient Sequence Number: 1
• Patient Age: 35 YR