MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF12, 5X100 KII FIOS ZTHR DP 10/BX; GCJ

Model Number	CTF12
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/27/2017
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 bent cannula and obturator.No fractures or cracks were observed on the cannula and the obturator was fragmented near the site of the bend.Based on the condition of the returned unit, it is likely that the reported event was caused by material degradation during the molding process, which could cause the part to be more susceptible to breaking during insertion.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.Based on the description of the event during initial intake of the complaint, the event was deemed non-reportable as it was unlikely to cause or contribute to death or serious injury.After evaluation by engineering, the event is now deemed reportable due to the fragmented obturator.This report represents the initial and final report.
Event or Problem Description
Procedure performed: laparoscopic cholecystectomy.Event description: surgeon using ctf12 in lap chole.At start of procedure during trocar insertion, the trocar bent.The trocar did not penetrate through the peritoneum.Trocars were replaced with another pack of ctf12 and case completed.Patient status: did a patient injury or illness occur associated with the complaint event? no.

• Brand Name: CTF12, 5X100 KII FIOS 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: 6793142
• Report Number: 2027111-2017-01947
• Device Sequence Number: 19296046
• Product Code: GCJ
• UDI-Device Identifier: 00607915125707
• UDI-Public: (01)00607915125707(17)200202(30)01(10)1288633
• 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
• Report Date (Section B): 08/14/2017

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: Health Professional
• Device Expiration Date: 02/02/2020
• Device Model Number: CTF12
• Device Catalogue Number: 101062401
• Device Lot Number: 1288633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2017
• Initial Report FDA Received Date: 08/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1