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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHROCARE CORP. EVAC 70 XTRA HP COBLATOR II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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ARTHROCARE CORP. EVAC 70 XTRA HP COBLATOR II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Catalog Number EIC5874-01
Device Problems Partial Blockage (1065); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/08/2018
Event Type  Injury  
Event Description
It was reported that the probe could not be effectively cut and ablated, and the probe was severely blocked, so it was impossible to continue the operation.When the incident occurred, a simple check of the equipment had been performed and the saline control valve, pedals and connection lines were checked and no abnormalities were found.There was a delay greater than 30 minutes.
 
Manufacturer Narrative
The returned device, used in treatment, was returned as an mdr for evaluation.There was no relationship found between the device and the reported incident.Visual inspection under magnification of the wand shows minimal electrode wear and scratch/scuff marks on the return electrode and spacer.The electrodes are strongly contaminated with unknown substances.There are no manufacturing abnormalities visually observed with the returned wand.During functional evaluation in the lab the returned wand was activated in saline solution using a known good coblator ii controller.The eic device was activated in saline solution on ablate- and coag mode and creates plasma on the electrodes as intended.The suction- and the saline line were tested and performed as intended.The complaint was not verified as the returned device performed as intended.The root cause could not be determined with confidence as several factors could contribute to the reported event.Factors unrelated to the design and manufacture of the device which could have contributed to the complaint event; e.G.(1) ensure suction is properly connected, if not, stop and connect suction (2) evac wands are designed for ablation and/or coagulation only.Therefore based on insufficient information, a clinical assessment cannot be performed at this time.
 
Event Description
It was reported that the probe could not be effectively cut and ablated, and the probe was severely blocked, so it was impossible to continue the operation.When the incident occurred, a simple check of the equipment had been performed and the saline control valve, pedals and connection lines were checked and no abnormalities were found.The failure cause a patient thermal damage.
 
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Brand Name
EVAC 70 XTRA HP COBLATOR II
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
jim gonzales
7000 west william cannon drive
austin, TX 78735
MDR Report Key7481935
MDR Text Key107329793
Report Number3006524618-2018-00220
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K070374
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberEIC5874-01
Device Lot Number1180256
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/09/2018
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/08/2018
Initial Date FDA Received05/02/2018
Supplement Dates Manufacturer Received06/12/2018
Supplement Dates FDA Received06/14/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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