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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPL VAS 2.7X30 DEG SH ARTHROSCOPE

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SMITH & NEPHEW, INC. SVCE REPL VAS 2.7X30 DEG SH ARTHROSCOPE Back to Search Results
Catalog Number 4131S
Device Problem Crack (1135)
Patient Problem No Patient Involvement (2645)
Event Date 08/14/2020
Event Type  malfunction  
Manufacturer Narrative
Device currently under investigation by the manufacturing registered site.
 
Event Description
It was reported that the scope is bent. No case reported; therefore, there was no patient involvement. Preliminary results of investigation have concluded that the scope had a cracked distal lens which 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 NameSVCE REPL VAS 2.7X30 DEG SH
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
Manufacturer (Section G)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key10694678
MDR Text Key211888853
Report Number3003604053-2020-00129
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K971253
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number4131S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/18/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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