MAUDE Adverse Event Report: INSIGHTRA MEDICAL FREEDOM PROFLOR; SURGICAL MESH

Model Number FIHR 25MM

Device Problem Material Rupture (1546)

Patient Problem No Code Available (3191)

Event Date 02/18/2016

Event Type  malfunction  

Manufacturer Narrative

It was noted that the doctor was not using an insightra medical delivery device for deploying the implant, but instead used their own delivery instruments consisting of forceps and pick-ups.These unqualified instruments can apply excessive forces to the implant during handling which was evident with the product that was returned for evaluation.

Event Description

A distributor reported that a customer experienced a preperitoneal disk separation from the core of a proflor implant, model fihr 25mm, when attempting to repair a 5mm hernia defect.Based on the report, preperitoneal disk separation occurred when the proflor implant lamella was being grasped with forceps while being placed in the hernia orifice.Another fihr 25mm implant from the same lot was used to successfully complete the procedure.There was no reported patient harm.

• Brand Name: FREEDOM PROFLOR
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): INSIGHTRA MEDICAL; 9200 irvine center drive; suite 200; irvine, ca 92618
• Manufacturer Contact: thomas colonna ; 9200 irvine center drive; irvine, CA 92618 ; 9492151835
• MDR Report Key: 5525186
• MDR Text Key: 41123550
• Report Number: 2032677-2016-00005
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K113552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/25/2017
• Device Model Number: FIHR 25MM
• Device Catalogue Number: FIHR 25MM
• Device Lot Number: 09251411
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2014
• 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: FORCEPS
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 47