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

Model Number LPG1510AL

Device Problem Torn Material (3024)

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

Event Date 02/14/2018

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 robotic laparoscopy while doing inguinal hernia repair, toward the end of the procedure when the mesh was implanted, as the surgeon was unfolding the mesh, it tore at the seam.The mesh was not cut prior to implantation, the wound was closed after the procedure by suture and the mesh was damaged.The torn mesh was removed and a new piece of mesh was implanted to complete the case.There was no patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance led an evaluation of one device.The visual examination of the returned sample shows that the sample was not returned in its original packaging.The mesh was placed in its blister and a part of its aluminum pouch.The mesh was found contaminated by blood.The mesh has been cut.The textile knitting and collagen part were found as expected.A hole is visible along the sewing between both parts of the mesh.The reported condition was confirmed.Excessive tension is highly suspected.The product ifu (instructions for use) which accompanies each device states: ¿warnings and precautions¿ that: if an anatomical mesh is re-cut, special care should be taken to preserve the sewing to limit the risk of recurrence.Excessive tension potentially increase by the cut of the mesh may have been applied.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROGRIP
• 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: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7351952
• MDR Text Key: 102850570
• Report Number: 9615742-2018-00558
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521513174
• UDI-Public: 10884521513174
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: LPG1510AL
• Device Catalogue Number: LPG1510AL
• Device Lot Number: PRF0382X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2017
• 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