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

Model Number SYM1510F

Device Problem Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/22/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a laparoscopic ventral hernia repair, during insertion into patient and using the absorbatack to fixate mesh onto the abdominal wall, a hole was shot in the mesh, resulting in a tack in the abdominal wall but no fixation for the mesh.The tack from the absorbatack shot a hole in the mesh.The device remains implanted.No injury to the patient.Tacks were fired normally from the device.The surgeon managed to fixate the mesh after the issue occurred.The surgeon succeeded in fixating the mesh with the absorbatack without making any more holes.

Manufacturer Narrative

Evaluation summary: a review of the device history record (dhr) has been performed.No failure that may relate to the reported conditions have been noted.The visual examination of the pictures shows that: 2 photos have been taken during the surgery.The sample was placed into the patient.The first photo shows that: one violet tack is clearly visible, placed at 3 stiches from the edge of the mesh.A hole was visible at the left of the tack described below.The brightness indicates the presence of the collagen on the mesh.Another purple mark placed on the left of the hole is visible but blurred.The second photo shows: 2 tacks fixed on the patient wall.The mesh is not placed on these but seems to be folded above.A yarn which seems to be of the mesh is visible near the tacker.The reported condition was confirmed.The product ifu (instructions for use) which accompanies each device states in chapter: operating steps that: the edge of the reinforcement should be at least 5 cm over the edges of the defect(s).The technique used to anchor the mesh (suture or staples) is left up to the practitioner.It is suggested to fixate the mesh at a distance of approximately 1cm from the edge of the mesh.Excessive tension is highly suspected.The report has been added to our database which is monitored for similar occurrences.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SYMBOTEX
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux CT 01600 ; FR 01600
• Manufacturer (Section G): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux CT 01600 ; FR 01600
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7385477
• MDR Text Key: 103973654
• Report Number: 9615742-2018-00634
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521190382
• UDI-Public: 10884521190382
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K131969
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: SYM1510F
• Device Catalogue Number: SYM1510F
• Device Lot Number: PRJ0819X
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/13/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2017
• 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