MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTB12, 5X100 KII SH BLD ZTHR DP 10/BX; GCJ

Model Number	CTB12
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complaint's experience of a fractured cannula tip.Based on the condition of the returned unit and the description of the event, it is likely that the reported event was caused by an instrument used during the procedure that was not fully closed while passing through the cannula tip.Material degradation during the molding process could cause the part to be more prone to brittle 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 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.This report represents the initial and final report.
Event or Problem Description
Procedure performed: ni.Event description: during a surgical procedure identification by operator of a sharp piece about 5mm in the patient's abdomen.Additional information received from territory manager on 11 january 2018: for the incident with the trocart there was a blue piece of the sleeve in the abdominal wall.The surgeon make his operation successfully but one nurse find this blue piece when they get out the trocart.Picture of the "sharp piece" is not available.Patient status: there was no patient injury.

• Brand Name: CTB12, 5X100 KII SH BLD ZTHR DP 10/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7214271
• Report Number: 2027111-2018-00031
• Device Sequence Number: 19138164
• Product Code: GCJ
• UDI-Device Identifier: 00607915123529
• UDI-Public: (01)00607915123529(17)200705(30)01(10)1300224
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K072674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/23/2018

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: 07/05/2020
• Device Model Number: CTB12
• Device Catalogue Number: 101413701
• Device Lot Number: 1300224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2017
• Initial Report FDA Received Date: 01/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1