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

Model Number	LPG1612AR
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a robotic right herniorrhaphy inguinal with mesh procedure, the surgeon pushed the mesh trough the trocar and into the patient's abdomen.The surgeon then began to unfold the mesh and a tear was noticed at the seam of the mesh.A new mesh was used to resolve the issue and complete the procedure.There was no patient injury.

• Brand Name: PROGRIP
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 11065645
• Report Number: 9615742-2020-02904
• Device Sequence Number: 16863043
• Product Code: FTL
• UDI-Device Identifier: 10884521513228
• UDI-Public: 10884521513228
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K143386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/23/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: LPG1612AR
• Device Catalogue Number: LPG1612AR
• Device Lot Number: PUB0914X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 95