• 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 Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/13/2021
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference: (b)(4).
 
Event Description
It was reported that, port a and b of the dii controller does not recognize the handpiece. No case reported; therefore, there was no patient involvement.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDII CONTROLLER
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107
Manufacturer (Section G)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key11882890
MDR Text Key257534152
Report Number1643264-2021-01975
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K062849
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 06/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72200873
Device Catalogue Number72200873
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/17/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-