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

Model Number	CTF12
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, a photograph of the shield, a clear plastic internal component of the seal, was provided by the complainant.Visual inspection confirmed the complainant's experience of shield dislodgement.Based on the photograph and the description of the event provided, it is likely that the reported event was caused when gauze was inserted through the trocar.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.This report represents the initial and final report.
Event or Problem Description
Procedure performed: inguinal hernia.Event description: during a laparoscopy (inguinal hernia), the surgeon noticed a resistance to the passage of instruments at the level of a trocar of 5mm.When checking the abdomen before closing, we noticed that the trocar valve had fallen into the belly of the patient (see photos attached by mail) we removed the valve during laparoscopy.Thanks to our vigilance none, but the small size of the object makes it not impossible that we do not see it if it re-occurred.Type of intervention: we removed the valve during laparoscopy.Patient status: ni.

• Brand Name: CTF12, 5X100 KII FIOS ZTHR DP 10/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RECOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7401292
• Report Number: 2027111-2018-00140
• Device Sequence Number: 11055964
• Product Code: GCJ
• UDI-Device Identifier: 00607915125707
• UDI-Public: (01)00607915125707(17)201003(30)01(10)1306916
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K041795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/05/2018

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: 10/03/2020
• Device Model Number: CTF12
• Device Catalogue Number: 101062401
• Device Lot Number: 1306916
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 04/05/2018
• Patient Sequence Number: 1