MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFF03, 5X100 KII FIOS ADVFIX 6/BX; GCJ

Model Number 14

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/17/2016

Event Type  malfunction  

Manufacturer Narrative

The event product was returned to applied medical for evaluation.Engineering did not observe any damage to the components of the seal.The shield was dislodged from the retaining groove.The root cause of the event is was caused by the dislodged shield.The shield dislodgement was likely caused by the removal and manipulation of the scissors after the silicone grease was removed from the septum, shield, and duckbill by the application of octenisept (product used by the customer).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 is being filed as a result of a re-review of applied medical complaints received between (b)(6) 2014 and (b)(6) 2016.This retrospective review was associated with a quality management system (qms) compliance action plan developed and presented to fda to address an (b)(6) 2015 warning letter.Applied medical has revised its mdr reporting criteria to be more conservative and has improved complaint handling and mdr reporting processes.The reviews ensured that recent reportable events were appropriately identified and reported to the designated regulatory authority(ies).This report, which represents the initial and final reports combined, is being submitted based on the findings of that retrospective review.

Event Description

Adhäsiolyse (procedure time: 4.5 hours) - "the leading surgery dr.(b)(6) used the trocar in a test-op.In this procedure he divided adhesions.The surgeon used the trocar to insert our scissor (b)(4).Dr.(b)(6) is not very content with our seals of our trocars.If he operate a long time with the trocar, the seal weren´t tight the whole procedure.In this operation he said, that the insertion of the scissor through our trocar wasn´t very easily.The shealth of the scissor rub against the seals.During the whole operation the nurse damped the shealth of the scissor with octenispet.Octenisept is a solution for wound disinfection.This two products are sterile sample of me.The customer doesn´t buy this products." patient status - no injury.

• Brand Name: CFF03, 5X100 KII FIOS ADVFIX 6/BX
• Type of Device: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138233
• MDR Report Key: 6372490
• MDR Text Key: 68823428
• Report Number: 2027111-2017-01289
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915117641
• UDI-Public: (01)00607915117641(17)171222(30)01(10)1236721
• Combination Product (y/n): N
• PMA/PMN Number: 14
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/02/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 12/22/2017
• Device Model Number: 14
• Device Catalogue Number: 14
• Device Lot Number: 1236721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/17/2016
• Initial Date FDA Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: '3 X STEELTROCAR OF STORZ AND 1 CTF03 (LOT 1236721