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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC ENDOPATH ETS-FLEX45 ARTICULATING ENDOSCOPIC LINEAR CUTTER; STAPLE, IMPLANTABLE
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ETHICON ENDO-SURGERY, LLC ENDOPATH ETS-FLEX45 ARTICULATING ENDOSCOPIC LINEAR CUTTER; STAPLE, IMPLANTABLE Back to Search Results
Model Number ATS45
Device Problem Defective Component (2292)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 05/15/2020
Event Type  malfunction  
Event Description
The stapler fired off well and once surgeon released stapler, after waiting the appropriate time, the stapler line was okay for about 5 seconds and the artery began to bleed, clips were used to stop the bleeding.Shortly after surgeon began to irrigate and it was noticed that the biliary duct began to leak from the stapled end.More clips were used to stop the leak.Following the incident, the manufacturer provided a tracking # and product return packaging for the defective product.
 
Event Description
The stapler fired off well and once surgeon released stapler, after waiting the appropriate time, the stapler line was okay for about 5 seconds and the artery began to bleed, clips were used to stop the bleeding.Shortly after surgeon began to irrigate and it was noticed that the biliary duct began to leak from the stapled end.More clips were used to stop the leak.Following the incident, the manufacturer provided a tracking # and product return packaging for the defective product.
 
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Brand Name
ENDOPATH ETS-FLEX45 ARTICULATING ENDOSCOPIC LINEAR CUTTER
Type of Device
STAPLE, IMPLANTABLE
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC
4545 creek rd.
cincinnati OH 45242
MDR Report Key10133086
MDR Text Key194489458
Report Number10133086
Device Sequence Number1
Product Code GDW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup
Report Date 05/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberATS45
Device Catalogue NumberATS45
Device Lot NumberT94V5U
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/26/2020
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/26/2020
Event Location Hospital
Date Report to Manufacturer06/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age21900 DA
Patient Weight73
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