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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VAS HD AC 4MM X 30 DEG ARTHROSCOPE

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SMITH & NEPHEW, INC. VAS HD AC 4MM X 30 DEG ARTHROSCOPE Back to Search Results
Model Number 72202959S
Device Problem Crack (1135)
Patient Problem No Information (3190)
Event Date 07/22/2020
Event Type  malfunction  
Manufacturer Narrative
The device, which was used in the procedure, was returned for evaluation. There was a relationship between the reported event and the device. A visual inspection was performed and showed the scope to have distal tip and fiber damage and a cracked and scratched distal lens. The root cause is contact with another source. A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture. A complaint history review found related failures; this failure mode will be trended to assess for any necessary corrective actions a device labeling/ifu review was performed and indicated instructions for use includes recommendations, instructions and precautionary statements for proper use of the product. The risk level based on severity and final occurrence is acceptable. This failure is confirmed not originate from manufacturing, packaging, or labeling defects. No manufacturing related defects were observed.
 
Event Description
It was reported that during knee scope procedure, the scope was scratched. A backup device was available to complete the procedure with no delay or patient injuries. Results of investigation have concluded that this unit has a cracked distal lens which makes it a reportable event. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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Brand NameVAS HD AC 4MM X 30 DEG
Type of DeviceARTHROSCOPE
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
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key10569711
MDR Text Key208105905
Report Number3003604053-2020-00110
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 health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72202959S
Device Catalogue Number72202959S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/31/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/02/2020
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 Unkown

Patient Treatment Data
Date Received: 09/22/2020 Patient Sequence Number: 1
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