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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED CORPORATION ARGON-ENH (SYSTEM 7500); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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CONMED CORPORATION ARGON-ENH (SYSTEM 7500); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Model Number SYSTEM 7500
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 12/06/2020
Event Type  malfunction  
Event Description
Level one trauma to or.Surgeon requested argon beam coagulator (abc).Brought into room, usual settings selected and did not work when surgeon attempted to use it.Pt continued to hemorrhage from liver laceration while we switched hand piece, grounding pad and argon tank to resolve problem to no avail.As surgeon was unable to control bleeding with cauterization she was forced to use fibrillar, surgi-cel and avitene.Pt eventually packed with 28 lap sponges and left open with abthera wound vac instead of a closed abdomen.
 
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Brand Name
ARGON-ENH (SYSTEM 7500)
Type of Device
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
CONMED CORPORATION
525 french road
utica NY 13502
MDR Report Key11139145
MDR Text Key225756760
Report Number11139145
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/16/2020,12/15/2020
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 Model NumberSYSTEM 7500
Device Catalogue NumberSYSTEM 7500
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/16/2020
Date Report to Manufacturer01/08/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age8395 DA
Patient Weight90
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