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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VIDEOARTHROSCOPE HD 4MM X 30 DEG
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SMITH & NEPHEW, INC. VIDEOARTHROSCOPE HD 4MM X 30 DEG Back to Search Results
Catalog Number 72202961S
Device Problem Material Opacification (1426)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/05/2018
Event Type  malfunction  
Event Description
It was reported that can't see through the device.A backup device was available to complete the procedure with no delay or patient injuries.
 
Manufacturer Narrative
An evaluation was performed by the supplier and could confirm the customer complaint for they can¿t see through the device.A visual inspection was performed and showed the scope to have severe distal tip damage and a dented outer tube with internal cracked lenses.This damage is caused by contact with another source.No manufacturing related defects were observed.
 
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Brand Name
VIDEOARTHROSCOPE HD 4MM X 30 DEG
Type of Device
ARTHROSCOPE
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 william cannon drive
austin, TX 78735
5123585706
MDR Report Key8033517
MDR Text Key126150124
Report Number3003604053-2018-00170
Device Sequence Number1
Product Code HRX
UDI-Device Identifier00885554024203
UDI-Public00885554024203
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K043395
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 11/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number72202961S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/15/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/27/2018
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 Unknown
Patient Sequence Number1
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