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: KARL STORZ GMBH & CO. KG LED POWER; LED LIGHT SOURCE
  • 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
 

KARL STORZ GMBH & CO. KG LED POWER; LED LIGHT SOURCE Back to Search Results
Model Number 20161420-1
Device Problems Computer Software Problem (1112); Use of Device Problem (1670); Human-Device Interface Problem (2949)
Patient Problem No Information (3190)
Event Date 02/03/2017
Event Type  malfunction  
Event Description
During the course of a meatotomy, the light source device was assumed to be on standby mode by the surgical staff.It was not in use by the surgeon at the time.When the device was examined following the procedure, it was noted that the design of the device is not user friendly and confusing.To place the device on standby, one has to press a power button next to the circular outlet for the fiberoptic cord and this button will light up.It makes it appear that the device is on and ready for use, when it is actually on standby mode.When you turn this power button off (take the device off of standby mode), the circular outlet for the fiberoptic cord and the display (indicating the intensity) lights up.Also, when the device is turned completely off and then back on, it defaults to the previous setting, whether it is at 0 or 100.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LED POWER
Type of Device
LED LIGHT SOURCE
Manufacturer (Section D)
KARL STORZ GMBH & CO. KG
2151 e grand avenue
el segundo CA 90245
MDR Report Key6484960
MDR Text Key72544383
Report Number6484960
Device Sequence Number1
Product Code NTN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/31/2017,04/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model Number20161420-1
Device Catalogue Number20161420
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/31/2017
Event Location Hospital
Date Report to Manufacturer03/31/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage N
Patient Sequence Number1
Treatment
NO; NO OTHER THERAPIES
Patient Age21 YR
Patient Weight73
-
-