MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS SYMBOTEX; MESH, SURGICAL, POLYMERIC

Model Number SYM2015OS

Device Problem Torn Material (3024)

Patient Problems Hernia (2240); Injury (2348); No Code Available (3191)

Event Date 06/15/2016

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter: the patient had robotic laparoscopic incisional hernia repair with component separation and while at the last step of application to cover hernia defect the mesh was used and 3 individual fixation systems.Approximately 2 months post op patient was seen back for possible recurrence.The patient underwent a reoperation approximately 3 months and 2 weeks post op and upon robotic access and visualization, it was discovered that the mesh had an opening in the center.This type of opening was consistent of a mesh fracture.The doctor closed the recurrent defect area with number 1 permanent suture and placed a new mesh.The mesh was secured using 2 sutures over the previously closed hernia.An additional procedure will be performed to correct the issue.The current patient status is alive with no injury.

• Brand Name: SYMBOTEX
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer (Section G): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6979381
• MDR Text Key: 90321486
• Report Number: 9615742-2017-05572
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131969
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SYM2015OS
• Device Catalogue Number: SYM2015OS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2017
• 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
• Patient Outcome(s): Other; Required Intervention