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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPL ASCOPE 1.9MM X 30 ARTHROSCOPE

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SMITH & NEPHEW, INC. SVCE REPL ASCOPE 1.9MM X 30 ARTHROSCOPE Back to Search Results
Model Number 4184S
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/1901
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference (b)(4). The reported device, intended for use in treatment, was received for evaluation there was a relationship found between the returned device and the reported incident. A visual inspection found bent needle, distal tip and fiber damage and scratched and cracked distal lens. A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution. The complaint was confirmed. Factors that could have contributed to the reported event include an impact event inconsistent with normal use. No containment or corrective actions are recommended at this time.
 
Event Description
It was reported that the tip of the arthroscope's lens was found to be damaged. No case reported. Results of investigation have concluded that this unit had a crack 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 ASCOPE 1.9MM X 30
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 Key11484025
MDR Text Key239815553
Report Number3003604053-2021-00088
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
Type of Report Initial
Report Date 03/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4184S
Device Catalogue Number4184S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/08/2021
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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