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

Model Number LPG1510AR

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Torn Material (3024)

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

Event Date 06/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, during a robotic laparoscopic inguinal hernia procedure (robot tapp) using a 10mm trocar.When using graspers to unfurl the mesh, a hole was easily created in the mesh during placement.To resolve the issue the damaged mesh was removed and replaced with a new piece of mesh.There was no injury as a result of the event.The patient status is alive with no injury.The mesh was not cut prior to the procedure.The mesh was not folded at the 2 violet expanders.The mesh was hydrated prior to use.There was no issue with the packaging.The current patient status is fine.

Manufacturer Narrative

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

Manufacturer Narrative

Evaluation summary: the visual examination of the sample shows that the sample was placed in a biohazard bag.The sample was returned in its original aluminum pouch, blister and tyvek.The temperature dot was white and the mesh was found contaminated by blood.The mesh was found folded in both corners at the other edge of the flap and the dimensions 15x10 are found as expected.The mesh was found torn along the sewing between the flap and the mesh.The hole is around 5 x 1 cm.The reported condition was confirmed.Excessive manipulation by the user is highly suspected.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: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6646911
• MDR Text Key: 77760057
• Report Number: 9615742-2017-05162
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521513167
• UDI-Public: 10884521513167
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: LPG1510AR
• Device Catalogue Number: LPG1510AR
• Device Lot Number: PRC0354X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2017
• 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