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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHROCARE CORP. AMBIENT HIPVAC 50 IFS ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

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ARTHROCARE CORP. AMBIENT HIPVAC 50 IFS ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Model Number 72290004
Device Problem Insufficient Information
Event Date 12/10/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that during hip arthroscopy, the wand showed an e7 error code. A backup device was available to complete the procedure with no delay or patient injuries. Results of investigation have concluded that the insulation on the shaft in this unit was damaged and compromised. This damaged of insulation may lead to transmission of current to skin or non-target tissue, which may result in a burn to the patient or user and this makes it a reportable event. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.

 
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Brand NameAMBIENT HIPVAC 50 IFS
Type of DeviceELECTROSURGICAL, 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 Key9772649
Report Number3006524618-2020-00083
Device Sequence Number1
Product CodeGEI
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 02/29/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/29/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number72290004
Device Catalogue Number72290004
Device LOT Number2027826
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/27/2019
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/17/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/02/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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