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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 Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/05/2017
Event Type  malfunction  
Event Description
It was reported that the scope has a crack.No patient injury was reported.
 
Manufacturer Narrative
An evaluation was performed by the supplier and could confirm the customer complaint for the scope has a crack.A visual inspection was performed and showed the scope to have distal tip and fiber damage with a scratched negative lens.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
MDR Report Key7124767
MDR Text Key95195997
Report Number3003604053-2017-00338
Device Sequence Number1
Product Code HRX
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,distri
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 01/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2017
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 Manufacturer12/14/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/03/2018
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 Reuse
Patient Sequence Number1
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