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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC ETHICON ECHELON FLEX POWERED VASCULAR STAPLER; STAPLE, IMPLANTABLE

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ETHICON ENDO-SURGERY, LLC ETHICON ECHELON FLEX POWERED VASCULAR STAPLER; STAPLE, IMPLANTABLE Back to Search Results
Model Number PVE35A
Device Problem Defective Component (2292)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/24/2019
Event Type  malfunction  
Event Description
During an appendectomy the device which cuts the appendix from its base while putting a double line of staples to either side of the incision, did not work.Though the ¿trigger¿ was pushed the device did not do what it was supposed to do.It was removed from the surgical field and replaced with a new one.Fda safety report id #(b)(4).
 
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Brand Name
ETHICON ECHELON FLEX POWERED VASCULAR STAPLER
Type of Device
STAPLE, IMPLANTABLE
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC
MDR Report Key9451041
MDR Text Key170675336
Report NumberMW5091561
Device Sequence Number1
Product Code GDW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/06/2019
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
Device Operator Health Professional
Device Expiration Date08/31/2011
Device Model NumberPVE35A
Device Lot NumberT94F1W
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/10/2019
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
Patient Age8 YR
Patient Weight25
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