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

Model Number CTF03

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The event device is anticipated to return to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.This report is to follow up medwatch report # (b)(4).

Event Description

Procedure performed: "umbilical hernia repair".Event description: medwatch report # (b)(4) received via mail on 25-apr-2018: date of event: (b)(6) 2018.A (b)(6) year old female, not hispanic/latino ethnicity."during the use of the trocar, the scope did not fit into the device." additional information was received via telephone from implementation specialist on monday 7-may-2018 at 11:17 am: rep stated he was not in the case.The facility was using the new [scope brand] system, which uses a larger outer diameter which led the scope to getting stuck on the fios obturator.Surgeon was dr.[].The device will be returning, but is with risk management.Patient status: no patient injury.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and the complainant's experience could not be replicated or confirmed.In the absence of the event unit, it is difficult to determine the exact root cause of the event.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 event is not reportable as it is unlikely to cause or contribute to death or serious injury.This report is to follow up medwatch report #4400150000-2018-8021.

• 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
• MDR Report Key: 7503570
• MDR Text Key: 108483767
• Report Number: 2027111-2018-00168
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915123550
• UDI-Public: (01)00607915123550(17)201130(30)01(10)1311487
• Combination Product (y/n): N
• PMA/PMN Number: K041795
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2020
• Device Model Number: CTF03
• Device Catalogue Number: 101138401
• Device Lot Number: 1311487
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/25/2018
• Patient Sequence Number: 1
• Treatment: SCOPE