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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, 70°, 4MM; ARTHROSCOPE
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SMITH & NEPHEW, INC. SERV REPL, A'SCOPE, A/C, HD, 70°, 4MM; ARTHROSCOPE Back to Search Results
Catalog Number 72202088S
Device Problem Image Display Error/Artifact (1304)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/15/2018
Event Type  malfunction  
Event Description
It was reported that the device was cloudy.No back up device was available.No patient injury reported.
 
Manufacturer Narrative
An evaluation was performed by the supplier and could confirm the customer complaint for the device is cloudy.A visual inspection was performed and showed the scope to have distal tip damage and 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
SERV REPL, A'SCOPE, A/C, HD, 70°, 4MM
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
AL   78735
MDR Report Key7632550
MDR Text Key112299930
Report Number3003604053-2018-00102
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K962075
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number72202088S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/11/2018
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/18/2018
Initial Date FDA Received06/23/2018
Supplement Dates Manufacturer Received08/07/2018
Supplement Dates FDA Received08/08/2018
Was Device Evaluated by Manufacturer? Yes
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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