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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
Model Number 72202961S
Device Problem Material Opacification (1426)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/29/2017
Event Type  malfunction  
Event Description
It was reported that it wasn't possible to see through the device.No patient injury reported.
 
Manufacturer Narrative
An evaluation was performed by the supplier and could confirm the customer complaint that it wasn't possible to see through the device.A visual inspection was performed and showed the scope to have damaged negative lens with distal tip and fiber damage.This 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
MDR Report Key7164640
MDR Text Key96486786
Report Number3003604053-2018-00004
Device Sequence Number1
Product Code HRX
UDI-Device Identifier00885554024203
UDI-Public(01)00885554024203
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 company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number72202961S
Device Catalogue Number72202961S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/08/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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