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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INCORPORATED ACUSNARE UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

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COOK INCORPORATED ACUSNARE UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number G22647
Device Problems Failure to Cut (2587); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/01/2020
Event Type  malfunction  
Event Description
Cook acusnare polypectomy snare (reference (b)(4) was deforming in the area adjacent to the opening/closing handle when being closed over tissue in the colon. Also when properly grounded and hooked to the erbe electrocautery machine in the room, the snare did not efficiently cut the tissue as expected. No documentation of event in operative note.
 
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Brand NameACUSNARE
Type of DeviceUNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
COOK INCORPORATED
750 daniels way
bloomington IN 47404
MDR Report Key10605657
MDR Text Key209144874
Report Number10605657
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/04/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG22647
Device Catalogue NumberASDB-15-015-S
Device Lot NumberW4343222
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/04/2020
Event Location Hospital
Date Report to Manufacturer09/30/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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