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. DII CONTROLLER; 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. DII CONTROLLER; ARTHROSCOPE Back to Search Results
Model Number 72200873
Device Problems Smoking (1585); Moisture or Humidity Problem (2986)
Patient Problem No Patient Involvement (2645)
Event Date 07/20/2020
Event Type  malfunction  
Event Description
It was reported that the dii controller had a short circuit failure, which resulted in smoke coming from the device.Incident occurred before the procedure; 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
The reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no issue was observed.Complaint of "short circuit" error message was confirmed.Product failed functional testing with a short circuit error in both mdu ports.Cause of errors is a defective electronic component on the main digital pcb.Product passed functional testing with a known good main pcb installed.The complaint was confirmed and the root cause has been determined to be a defective electronic component.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 complaint history review concluded this was a repeat issue.
 
Manufacturer Narrative
The reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no issue was observed.Complaint of "short circuit" error message was confirmed.Product failed functional testing with a short circuit error in both mdu ports.Cause of errors is a defective electronic component on the main digital pcb.Product passed functional testing with a known good main pcb installed.The complaint was confirmed and the root cause has been determined to be a defective electronic component.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 at the time of manufacture in 2010, release from service in 2014, or release from service in 2015.A complaint history review concluded this was a repeat issue.A corrective action was previously initiated in august of 2017 to mitigate future recurrence of similar events.Following the completion of the root cause investigation, the capa included the incorporation of a design enhancement in august of 2018 to remove potential ground path(s) of components.A verification of effectiveness was successfully completed which demonstrated effectiveness of the design enhancement (including a determination that there were no confirmed instances of this failure mode occurring on units incorporating the enhanced design during the review period).As the subject device was manufactured/serviced prior to the implementation of the design enhancement, no further actions in relation to this event are deemed necessary at this time.
 
Manufacturer Narrative
The reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no issue was observed.Complaint of "short circuit" error message was confirmed.Product failed functional testing with a short circuit error in both mdu ports.Cause of errors is a defective electronic component on the main digital pcb.Product passed functional testing with a known good main pcb installed.The complaint was confirmed and the root cause has been determined to be a defective electronic component.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 complaint history review concluded this was a repeat issue.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DII CONTROLLER
Type of Device
ARTHROSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107
MDR Report Key10438885
MDR Text Key203911042
Report Number1643264-2020-00920
Device Sequence Number1
Product Code HRX
UDI-Device Identifier03596010607409
UDI-Public03596010607409
Combination Product (y/n)N
PMA/PMN Number
K062849
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup,Followup
Report Date 10/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number72200873
Device Catalogue Number72200873
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/05/2020
Date Manufacturer Received10/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-