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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. A'SCOPE, A'CLAVE, HD, 4MM X 70° ARTHROSCOPE

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SMITH & NEPHEW, INC. A'SCOPE, A'CLAVE, HD, 4MM X 70° ARTHROSCOPE Back to Search Results
Catalog Number 72202088
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/11/2018
Event Type  malfunction  
Event Description
It was reported that the device had a burn mark on the end. There was no delay or patient injury reported.
 
Manufacturer Narrative
Additional information was received that identified that this event should be re-evaluated for mdr reporting. The reassessment determined that the issue does not meet the threshold for reporting and is a non-reportable event. This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date.
 
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Brand NameA'SCOPE, A'CLAVE, HD, 4MM X 70°
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
MDR Report Key7635012
MDR Text Key112360393
Report Number3003604053-2018-00107
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
PMA/PMN Number
K962075
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 08/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72202088
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/20/2018
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/20/2018
Is This a Reprocessed and Reused Single-Use Device? No

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