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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
Model Number 72202087S
Device Problem Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
It was reported that during an unknown procedure, the lens on the scope was moving. No backup device was available and no delay or 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 Key9540055
MDR Text Key179442885
Report Number3003604053-2020-00001
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 company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72202087S
Device Catalogue NumberED72202087S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/24/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/23/2020
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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