Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CONTROL UNIT DYONICS 25; ARTHROSCOPE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITH & NEPHEW, INC. CONTROL UNIT DYONICS 25; ARTHROSCOPE Back to Search Results
Catalog Number 7211010
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that during a shoulder arthroscopy the dyonics 25 was over pressuring.The procedure was completed with the same device by setting lower pressure levels.No significant delay and no patient injury was reported due to the device malfunction.
 
Manufacturer Narrative
The reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.No product identification information was provided and thus a manufacturing record review could not be conducted.Please refer to the dyonics 25 fluid management system operations/service manual for warnings and precautions to prevent an over-pressurization event.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CONTROL UNIT DYONICS 25
Type of Device
ARTHROSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107 6512
MDR Report Key8701319
MDR Text Key148071399
Report Number1643264-2019-00406
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
PMA/PMN Number
K171794
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial,Followup
Report Date 07/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number7211010
Was Device Available for Evaluation? No
Date Manufacturer Received07/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-