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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHROCARE CORP. COBLATION HALO WAND; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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ARTHROCARE CORP. COBLATION HALO WAND; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Model Number 72290134
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/13/2022
Event Type  malfunction  
Event Description
It was reported that, during set up, at the moment of bending two (2) coblation halo wands with the evac bending tool, the electrode came apart, the electrode tip loosen and kinked saline line on the wand.There was a back-up device available and no delay was reported.There was no patient involvement.
 
Manufacturer Narrative
Internal complaint reference: (b)(4).
 
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Brand Name
COBLATION HALO WAND
Type of Device
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
ARTHROCARE CORP.
7000 w. william cannon
austin TX 78735
Manufacturer (Section G)
ARTHROCARE CORP.
7000 w. william cannon
austin TX 78735
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key15157370
MDR Text Key297230179
Report Number3006524618-2022-00338
Device Sequence Number1
Product Code GEI
UDI-Device Identifier00885556699928
UDI-Public00885556699928
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K192027
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 08/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/01/2023
Device Model Number72290134
Device Catalogue Number72290134
Device Lot Number2055223
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2022
Date Manufacturer Received07/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/22/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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