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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO SURGERY ETHICON, ECHLEON FLEX 35
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ETHICON ENDO SURGERY ETHICON, ECHLEON FLEX 35 Back to Search Results
Model Number 00343
Device Problems Break (1069); Detachment Of Device Component (1104); Sticking (1597); Gas/Air Leak (2946); Torn Material (3024)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/14/2017
Event Type  Injury  
Event Description
During a laparoscopic appendectomy, ethicon 35mm pvae35a stapler was passed through a 12mm covidien step trocar.There was a slow co2 leak around the stapler shaft.Appendix was successfully stapled off, but a second load was needed to staple mesentery.Surgeon attempted to remove stapler, but the flexible gasket around the stapler's articulation joint was getting stuck.Multiple attempts were made to remove stapler, causing his gasket to tear and insufflation port broken off side of trocar.We will be sending back to the manufacturer.Was able to remove this and enter a new trocar and stapler to complete the procedure.
 
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Brand Name
ETHICON, ECHLEON FLEX 35
Type of Device
ECHLEON FLEX 35
Manufacturer (Section D)
ETHICON ENDO SURGERY
cincinnati OH 45242 2839
MDR Report Key6420304
MDR Text Key70622410
Report NumberMW5068547
Device Sequence Number1
Product Code GAG
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 03/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2019
Device Model Number00343
Device Lot NumberP91689
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
ECHLEON FLEX POWERED VASCULAR STAPLER; EF # PVE35A ETHICON ENDO-SURGERY
Patient Outcome(s) Required Intervention;
Patient Age9 YR
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