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

Model Number LPG1510

Device Problem Failure To Adhere Or Bond (1031)

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

Event Date 05/18/2018

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 left inguinal herniorrhaphy procedure, the mesh was placed through the trocar and would not unfurl properly.The mesh was hydrated, and rolled up for insertion through the trocar.Once it was in the patient, the surgeon had difficulty keeping the mesh laid out and it kept rolling back up.The mesh was removed and replaced with another to complete the case.There was no patient injury.

Manufacturer Narrative

Evaluation summary: the sample was returned in its original tray and lid packaging.The reported condition was confirmed.A review of the device history record and visual examination has been performed.No failure or ncr that may relate to the reported conditions have been noted.The root cause could not be determined.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a robotic laparoscopic left inguinal herniorrhaphy procedure, the mesh was placed through the trocar and would not unfurl properly.Once it was in the patient, the surgeon had difficulty keeping the mesh laid out and it kept rolling back up.The mesh was removed and replaced with another to complete the case.There was no patient injury.

Manufacturer Narrative

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: 7569518
• MDR Text Key: 110084832
• Report Number: 9615742-2018-01229
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521513136
• UDI-Public: 10884521513136
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: LPG1510
• Device Catalogue Number: LPG1510
• Device Lot Number: PRL1134X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/28/2017
• 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