MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTB10, 5X150MM KII BLD DUAL ZTHR 10/BX; GCJ

Model Number	CTB10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event product was returned to applied medical for evaluation.Upon inspection, engineering confirmed the complainant's experience of a fractured cannula.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 probability and criticality of harm resulting from this failure mode 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 incident to occur.This report is being filed as a result of a re-review of applied medical complaints received between june 1, 2014 and may 31, 2016.This retrospective review was associated with a quality management system (qms) compliance action plan developed and presented to fda to address an april 10, 2015 warning letter.Applied medical has revised its mdr reporting criteria to be more conservative and has improved complaint handling and mdr reporting processes.The reviews ensured that recent reportable events were appropriately identified and reported to the designated regulatory authority(ies).This report, which represents the initial and final reports combined, is being submitted based on the findings of that retrospective review.
Event or Problem Description
Lap cholecystectomy: "consultant placed trocar correctly and trocar was fully functioning throughout operation.When the consultant remoted the trocar at the end of the procedure the trocar broke in the middle.It is thought no parts were left unintentionally in the patient and the trocar is complete.Please contact the lead nurse via email to arrange collection of the trocar." patient status- ok.

• Brand Name: CTB10, 5X150MM KII BLD DUAL ZTHR 10/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6393666
• Report Number: 2027111-2017-01457
• Device Sequence Number: 16343086
• Product Code: GCJ
• UDI-Device Identifier: 00607915124007
• UDI-Public: (01)00607915124007(17)171102(30)01(10)1233879
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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): 03/09/2017

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: 11/02/2017
• Device Model Number: CTB10
• Device Catalogue Number: 101065701
• Device Lot Number: 1233879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2015
• Initial Report FDA Received Date: 03/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GRASPER, HOOK, CLIP APPLIER