MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF71, KII FIOS 12X150MM Z-THREAD, 6BX; GCJ

Model Number	CTF71
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device has been returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: unknown.Event description: information received via email from sales representative on 05 dec 2017: bariatric patient, who was approx (b)(6) kg.Trocar is inserted into abdomen and the procedure started.Half was through the procedure, the scope was taken out to clean.When scope was inserted back into the trocar, miss [name] noticed that the trocar has cracked and tissue was coming through.Miss [name] decided to continue with this trocar as it would be difficult to insert another one.The case was completed with the affected trocar.Patient status: did a patient injury or illness occur associated with the complaint event? no patient was fine.No medical or surgical intervention was needed.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience of a fractured cannula.Based on the condition of the returned unit and the description of the event, it is likely that the reported event was caused by uneven 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: CTF71, KII FIOS 12X150MM Z-THREAD, 6BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7083019
• Report Number: 2027111-2017-02139
• Device Sequence Number: 11051932
• Product Code: GCJ
• UDI-Device Identifier: 00607915125035
• UDI-Public: (01)00607915125035(17)191216(30)01(10)1285762
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K041795
• 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): 12/15/2017

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: 12/16/2019
• Device Model Number: CTF71
• Device Catalogue Number: 101470688
• Device Lot Number: 1285762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2017
• Supplement Date Received by Manufacturer: 10/27/2017
• Initial Report FDA Received Date: 12/05/2017
• Supplement Report FDA Received Date: 12/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1