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

Model Number LPG1510AL

Device Problem Torn Material (3024)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 05/31/2018

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 laparoscopic inguinal hernia procedure, the mesh ripped in half while grabbing it with the instrument and trying to place the mesh in the spot of the defect.The mesh was taken out and another piece of mesh was put in.Extracting the mesh and getting more mesh in the space took more than 30 minutes of time.There was no patient injury.

Manufacturer Narrative

Evaluation summary: a review of the device history record (dhr) has been performed by quality assurance.No failure or ncr that may relate to the reported conditions have been noted.Especially the review of qc records related to the mechanical testing of the textile batches were found within specifications.The visual examination of the provided sample shows that the sample was returned in its original tray and lid packaging.It was placed in a biohazard tyvek pouch.The sample was found contaminated by blood.Mesh dimension, textile knitting and collagen film were found as expected.A 7 cm tear was found along the sewing of the flap.The sample has been folded grip side against grip side.The visual examination of the provided sample confirmed the reported condition.Each device is manually controlled at the stitching step and a visual examination is performed by the sewing operator.Such a defect would have been detected and the product rejected.It should be noted that the mesh was folded grip against grip.The product ifu which accompanies each device states in chapter ¿operating steps¿ that ¿3.Rolling/folding of the mesh: (¿) b.For the anatomical mesh, it is recommended to fold the mesh on itself, grips outside, length-wise, starting at the anatomical flap seam¿.The incident report states that the trocar size used was 8.The product ifu which accompanies each device states in chapter ¿operating steps¿ that ¿4.Grasp the mesh at either end and insert it through the 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¿.A search of our global complaints database revealed that this was the only report on file for this lot of product.The review of historical data indicates that 15 cases coded as "mesh torn".It should be noted that 7 of these cases concluded as misuse or not confirmed.The report has been added to our product complaints database which is monitored for similar occurrences.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.No immediate action required.The investigation revealed the cause to be user error.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: 7625588
• MDR Text Key: 111903790
• Report Number: 9615742-2018-01352
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: LPG1510AL
• Device Catalogue Number: LPG1510AL
• Device Lot Number: PRH0987X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2017
• 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 Age: 50 YR