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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SERV REPL, A'SCOPE, A/C, HD, 30°, 4MM ARTHROSCOPE

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SMITH & NEPHEW, INC. SERV REPL, A'SCOPE, A/C, HD, 30°, 4MM ARTHROSCOPE Back to Search Results
Catalog Number 72202087S
Device Problem Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/05/2019
Event Type  malfunction  
Event Description
It was reported that during an unknown procedure, the device had a quality issues. No backup device was available. No delay and no patient injuries were reported. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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Brand NameSERV REPL, A'SCOPE, A/C, HD, 30°, 4MM
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 Key9380760
MDR Text Key179441885
Report Number3003604053-2019-00138
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K962075
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 12/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72202087S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/19/2019
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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