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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SERVICE REP,VAS,2.7X30 DEG,SH,; ARTHROSCOPE
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SMITH & NEPHEW, INC. SERVICE REP,VAS,2.7X30 DEG,SH,; ARTHROSCOPE Back to Search Results
Catalog Number 4131S
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 03/19/2020
Event Type  malfunction  
Event Description
It was reported that the scope was scratched.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
 
Manufacturer Narrative
H11: further assessment of information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The information states that no harm nor injury was reported and no previous injury or harm has been confirmed to be caused by the device in the past, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
 
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Brand Name
SERVICE REP,VAS,2.7X30 DEG,SH,
Type of Device
ARTHROSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
150 minuteman road
andover MA 01810
MDR Report Key10031227
MDR Text Key194448680
Report Number3003604053-2020-00036
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
PMA/PMN Number
K971253
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/21/2020
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 Number4131S
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/14/2020
Initial Date FDA Received05/06/2020
Supplement Dates Manufacturer Received05/21/2020
Supplement Dates FDA Received05/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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