MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF03, 5X100 KII FIOS Z-THR 6/BX; GCJ

Model Number CTF03

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2017

Event Type  malfunction  

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience of damaged cannula and obturator.Based on the condition of the returned unit, it is likely that the reported event was caused by process variations during the manufacturing process in combination with the force applied during insertion.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.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 combined initial and final.

Event Description

Procedure performed: lap chole and lap incisional hernia repair.Event description: dr.[name]was inserting the trocar on the patient's right side for the lateral port.The surgeon went to the patients right side for insertion of the trocar and when attempting to insert the device, the cannula and obturator both bent to a 45 degree angle.The device did not penetrate the peritoneum.No patient injury.The device was replaced and the case continued without further incident.The patient is obese and has had a previous mid-line surgery.The trocar was not placed in the previous mid-line scar.A picture of the device is available.The device is available for return.The surgeon has used the trocars multiple times in the past and the surgeon noted that the incision was the typical size as executed in the past.The device was discarded and later retrieved for return.Multiple cannulas were used and discarded along with the event device.The lot #s of the cannulas used are not available as the packaging were discarded.Additional information was received via email on 29 nov 2017 on 5:46am, from account manager: two photographs were provided.Type of intervention: a new device was opened and used to complete the case without further incident.Patient status: no patient injury.

• Brand Name: CTF03, 5X100 KII FIOS Z-THR 6/BX
• Type of Device: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: wendy kobayashi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138059
• MDR Report Key: 7216418
• MDR Text Key: 98295127
• Report Number: 2027111-2018-00025
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915123550
• UDI-Public: (01)00607915123550(17)200928(30)01(10)1306184
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041795
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2020
• Device Model Number: CTF03
• Device Catalogue Number: 101138401
• Device Lot Number: 1306184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1