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

Model Number LPG1510AL

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 09/14/2018

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 inguinal hernia repair, the scrub tech rolled the mesh, the damage was not noticed before insertion into the trocar.As the surgeon was unrolling the mesh, a hole in the inferior portion of the mesh was noticed.The tear was where the seam is on the inferior portion of the mesh.Took the mesh out and replaced to complete the case.No injury.

Manufacturer Narrative

Evaluation summary: one device was received for evaluation.A review of the device history record has been performed by (b)(6).No failure or ncr that may relate to the reported conditions have been noted.The visual examination of the returned sample shows that the sample was returned in its commercial box.A picture was attached too.It shows the surgery of mesh implantation, placed with surgical forceps.A barbed suture yarns placed on the abdominal wall is visible too.The sample was returned in a jar/pot with an unknown liquid.The textile knitting pattern and the sewing were found as expected.The mesh has been cut (initial mesh dimension 15 x 10 cm ¿ sample dimension found 15 x 8 cm).The collagen film could not be verified because the mesh was wet.A hole of around 4,5 cm was found along the sewing between the flap and the mesh.The sample has been folded on itself length-wise, flap side: grips inside and opposite side of the flap grips outside.No tears are visible around the hole.The sewing green yarn was visible but disjointed.Conclusion of the visual examination: the reported condition was confirmed.It should be noted that the mesh was placed with a robotic-assistance to repair left inguinal hernia.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 10 mm internal diameter to introduce a mesh of size up to 15x10 cm and a trocar of at least 12 mm internal diameter to introduce a mesh of size 16x12 cm or above¿.It was mentioned in the report that a 8 cm trocar was used during the surgery.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.In conclusion, the reported condition was confirmed by the returned sample.A user error is highly suspected.The physician used an 8 mm trocar instead of a trocar of at least 10 mm internal diameter to introduce the mesh lpg1510al.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: 7947084
• MDR Text Key: 123409654
• Report Number: 9615742-2018-02255
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: LPG1510AL
• Device Catalogue Number: LPG1510AL
• Device Lot Number: PSA0055X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2018
• Initial Date FDA Received: 10/09/2018
• Supplement Dates Manufacturer Received: 11/19/2018
• Supplement Dates FDA Received: 12/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2018
• 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