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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DYONICS 25 INFLOW ONLY TUBE SET (3) ARTHROSCOPE

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SMITH & NEPHEW, INC. DYONICS 25 INFLOW ONLY TUBE SET (3) ARTHROSCOPE Back to Search Results
Catalog Number 7211004
Device Problem Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/18/2019
Event Type  malfunction  
Manufacturer Narrative
Foreign zip code: (b)(6).
 
Event Description
It was reported that, during a knee arthroscopy, the dyonics 25 inflow-only tube set had low pressure. The procedure was successfully finished, but it is unknown how since a back-up device was not available. Surgery was not delayed. The patient was not harmed. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
Manufacturer Narrative
The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed. A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended. A relationship, if any, between the subject device and the reported event could not be determined. If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
 
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Brand NameDYONICS 25 INFLOW ONLY TUBE SET (3)
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
Manufacturer (Section G)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key9302522
MDR Text Key165795903
Report Number1643264-2019-00765
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K051326
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2022
Device Catalogue Number7211004
Device Lot Number50799490
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/16/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/12/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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