MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTR72,12X150 KII OPT ZTHR HDL 6/BX; GCJ

Model Number	CTR72
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2017
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: sleeve gastrectomy.Event description: the trocar broke inside the wall.Original: le trocart d/2eme c'est cassé dans la paroi.Additional information received from the sales rep via email on 13 june 2017 at 11:54am: the complete device is available for evaluation.The cannula is broken in 2.The breakage is in the middle of the cannula, on the thread.The surgeon introduced a 5mm instrument (probably a grasper but he is not sure).He wanted to guide the instrument where he wanted work.Perhap's the cannula was not well oriented.And he saw that the cannula was broken approximatively in the middle of the surgery.It was a clean break.The port was not used with a robot.The method of insertion was classic insertion, it's not the first trocart, so he can see trocart during introduction.The 2 broken pieces were retrieved from the patient.Type of intervention: unknown.Patient status: the patient is good now, the incident has no impact on the patient status during or after the surgery.
Additional Manufacturer Narrative
The event product was returned to applied medical for evaluation.Upon inspection, engineering was able to confirm 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 has implemented process enhancements intended to further minimize the potential for this type of incident to occur.

• Brand Name: CTR72,12X150 KII OPT ZTHR HDL 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6668907
• Report Number: 2027111-2017-01872
• Device Sequence Number: 46639
• Product Code: GCJ
• UDI-Device Identifier: 00607915125059
• UDI-Public: (01)00607915125059(17)190907(30)01(10)1278808
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K060096
• 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,Followup
• Report Date (Section B): 08/22/2017

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: 09/07/2019
• Device Model Number: CTR72
• Device Catalogue Number: 101418101
• Device Lot Number: 1278808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2017
• Supplement Date Received by Manufacturer: 06/07/2017
• Initial Report FDA Received Date: 06/26/2017
• Supplement Report FDA Received Date: 08/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1