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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 Image Display Error/Artifact (1304)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that the scope has a cloudy view. There was no backup device available. No delay or patient injury reported.
 
Manufacturer Narrative
Additional information received by the manufacturer has 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 due to the event occurred before the procedure and there was no patient contact. 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 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
jim gonzales
7000 west wiliam cannon dr.
austin, TX 78735
5123585706
MDR Report Key8206105
MDR Text Key131744782
Report Number3003604053-2018-00198
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K962075
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/07/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number72202087S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/07/2019
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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