MAUDE Adverse Event Report: SOFRADIM PRODUCTION LP PRGRP ANTMCL MSH10X15CM RT; MESH, SURGICAL, POLYMERIC

Model Number LPG1510AR

Device Problems Out-Of-Box Failure (2311); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, the mesh was torn along the seam.It was discovered during implantation as the mesh was being unrolled.There were no adverse events as a result of the reported issue.

Manufacturer Narrative

Tracking number: (b)(4).

Event Description

Per additional information, the procedure performed was a right robotic inguinal hernia.The hole in the device was observed when the mesh was initially being placed, and to resolve the issue, the surgeon removed the mesh from the patient and placed a new mesh over the defect.The surgeon used a bipolar arm and a needle driver to fixate the mesh.No suture or tacks were used.The hole was observed to be along the "seam" of the device, close to the medical marker on the mesh.The mesh was not cut by the surgeon and the trocars were 8mm.

Manufacturer Narrative

(b)(4) evaluation summary: the visual examination of the returned sample shows the following: the sample was returned only in a blister.The mesh was clinically used (bloody).There is a felt-pen line at the collagen film part location, grip pins side.The mesh is damaged at 2 different locations: a 2 cm hole in the seam near the green band, and an overstretched tear at the opposite side of the seam.One of the seam threads is broken.The rest of the seam appears as expected.Per information received, the physician used an 8mm trocar.It is recommended to use a trocar of at least 10mm internal diameter to introduce a mesh of size up to 15x10 cm and a trocar of at least 12mm internal diameter to introduce a mesh of size 16x12 cm or above.Based on our investigation and a complaint history review, the manufacture of the device is not suspected.There is no indication that there is a defective lot or that this event represents an emerging adverse quality trend.Based on the available information (use of an 8mm trocar instead of a trocar of at least 10mm internal diameter to introduce the mesh lpg1510ar), the handling rough of the mesh through the trocar is highly suspected.This was concluded to be user error.The physician used an 8mm trocar instead of a trocar of at least 10mm internal diameter to introduce the mesh lpg1510ar.This is an off-label.

• Brand Name: LP PRGRP ANTMCL MSH10X15CM RT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• Manufacturer (Section G): SOFRADIM PRODUCTION; 116 avenue du formans; trevoux ; FR
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 5346654
• MDR Text Key: 35608452
• Report Number: 9615742-2016-00001
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LPG1510AR
• Device Catalogue Number: LPG1510AR
• Device Lot Number: RPE0801X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1