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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPDIE MEDICAL SURGIMESH XB; TINTRA C-10
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ASPDIE MEDICAL SURGIMESH XB; TINTRA C-10 Back to Search Results
Model Number SURGIMESH XB
Device Problem Device Issue (2379)
Patient Problem Missing Value Reason (3192)
Event Date 01/10/2017
Event Type  Injury  
Event Description
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.
 
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Brand Name
SURGIMESH XB
Type of Device
TINTRA C-10
Manufacturer (Section D)
ASPDIE MEDICAL
246 allee lavoisier
latalaudiere, france 42350
FR  42350
MDR Report Key6313008
MDR Text Key66859153
Report Number3005841068-2017-00001
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 02/08/2017,02/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Expiration Date06/19/2020
Device Model NumberSURGIMESH XB
Device Catalogue NumberTINTRA C-10
Device Lot NumberF12007A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/08/2017
Distributor Facility Aware Date01/10/2017
Event Location Hospital
Date Report to Manufacturer02/08/2017
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age21 YR
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