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: DAI-ICHI SHOMEI SKYTRON; SURGICAL LIGHT
  • 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
 

DAI-ICHI SHOMEI SKYTRON; SURGICAL LIGHT Back to Search Results
Model Number ST23
Device Problem Material Fragmentation (1261)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/13/2015
Event Type  Injury  
Event Description
During a surgical procedure, hospital staff noted white plastic pieces floating down from the surgical light into the sterile field.No injuries were reported.The surgery was completed as scheduled.Upon investigation, facility's biomed noted that the end cap of the light was damaged and appeared to be chipped away from use and potential collision with other equipment.All surgical lights in the facility were inspected and other lights were found to be in a similar condition.Facility ordered replacement caps for and will replace them upon receipt.Facility is returning damaged caps to (b)(4) for further evaluation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SKYTRON
Type of Device
SURGICAL LIGHT
Manufacturer (Section D)
DAI-ICHI SHOMEI
tokyo
JA 
MDR Report Key4947366
MDR Text Key6036231
Report Number1825014-2015-00032
Device Sequence Number1
Product Code EBA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Source Type Unknown
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 07/21/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberST23
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/20/2015
Distributor Facility Aware Date07/14/2015
Device Age12 YR
Event Location Hospital
Date Report to Manufacturer07/21/2015
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-