MAUDE Adverse Event Report: ASPIDE MEDICAL SURGIMESH XB; MESH, SURGICAL, POLYMERIC

Model Number SURGIMESH XB

Device Problem Device Issue (2379)

Patient Problem Missing Value Reason (3192)

Event Date 01/10/2017

Event Type  malfunction  

Manufacturer Narrative

The distributor specified in the declaration the following : " the torn xb c-10 was forwarded so we could examine the tear.The rough edge of the tear demonstrated evidence of excessive force placed on the material.".Examination of the lot file of the incriminated device reveiled no quality or manufacturing problem.

Event Description

The distributor reported that : the surgeon was repairing an umbilical hernia and tried to take an xb c-10 cut down to approximately 7 cm in diameter down a 5mm trocar using a laparoscopic grasper.The grasper/cut down xb c-10 got stuck part way down.Upon removing the grasper/xb c-10, the xb c-10 was torn in half.He requested another xb c-10 and completed the procedure without incident.We were contacted to replace the torn xb c-10 which was done.The torn xb c-10 was forwarded so we could examine the tear.The rough edge of the tear demonstrated evidence of excessive force placed on the material.

• Brand Name: SURGIMESH XB
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ASPIDE MEDICAL; 246 allee lavoisier; la talaudiere, 42350 ; FR 42350
• Manufacturer (Section G): ASPIDE MEDICAL; 246 allee lavoisier; la talaudiere, 42350 ; FR 42350
• Manufacturer Contact: sid ahmed tadjer ; 246 allee lavoisier; la talaudiere, 42350 ; FR 42350 ; 77531659
• MDR Report Key: 6363593
• MDR Text Key: 68515199
• Report Number: 3006617478-2017-00001
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/11/2016,02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/19/2020
• Device Model Number: SURGIMESH XB
• Device Catalogue Number: TINTRAC 10
• Device Lot Number: F12007A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/11/2016
• Date Report to Manufacturer: 04/25/2016
• Date Manufacturer Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2014
• 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