MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CNO11, GELPOINT PATH 5.5CM; FER

Model Number 15

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2015

Event Type  malfunction  

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Upon inspection, engineering confirmed the customer experience that one sleeve had separated from its septum.A review of the manufacturing records for the lot number provided revealed that the product passed all quality and manufacturing inspections.The root cause of the separated septum is the swab being pushed through.It is likely the swab was not lubricated and the highly textured surface of the material would cause enough friction to push the septum out of the sleeve.If an aggressive angle was used to insert and remove the swab this could have contributed to the septum separation.The instructions for use caution ""to minimize eversion of the sleeves seal, instruments with high textured surfaces should be coated with a sterile lubricant." in addition, "all instruments should be centered axially when inserted through the sleeves seal for easier insertion." this report is being filed as a result of a re-review of applied medical complaints received between june 1, 2014 and may 31, 2016.This retrospective review was associated with a quality management system (qms) compliance action plan developed and presented to fda to address an april 10, 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.In accordance to 21 cfr 803.56, if additional information is obtained which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.

Event Description

Tamis- "surgeon put a little swap through.Swap pulled of the seal.It was torn off.Swap was stuck on the seal." patient status - "patient is ok".

• Brand Name: CNO11, GELPOINT PATH 5.5CM
• Type of Device: FER
• 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: 6385922
• MDR Text Key: 69328711
• Report Number: 2027111-2017-01490
• Device Sequence Number: 1
• Product Code: FER
• UDI-Device Identifier: 00607915124755
• UDI-Public: (01)00607915124755(17)170429(30)01(10)1221910
• Combination Product (y/n): N
• 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: 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2017
• Device Model Number: 15
• Device Catalogue Number: 15
• Device Lot Number: 1221910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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
• Treatment: 5MM TROKAR COVIDIEN, OCTUPORT, AIRSEAL TROKAR 12MM