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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KARL STORZ SE & CO. KG POWER LED 175, W/O ACC.
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KARL STORZ SE & CO. KG POWER LED 175, W/O ACC. Back to Search Results
Model Number 20161420-1
Medical Device Problem Code Overheating of Device (1437)
Health Effect - Clinical Code Bradycardia (1751)
Date of Event 01/01/2023
Type of Reportable Event Serious Injury
Event or Problem Description
It has been reported the staff has received burns from the light lead caused by this device.
 
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
 
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Brand Name
POWER LED 175, W/O ACC.
Common Device Name
POWER LED
Manufacturer (Section D)
KARL STORZ SE & CO. KG
dr.-karl-storz-strasse 34
tuttlingen, 78532
GM  78532
MDR Report Key16354004
Report Number2020550-2023-00038
Device Sequence Number6432291
Product Code NTN
UDI-Device Identifier04048551288900
UDI-Public4048551288900
Combination Product (Y/N)N
Initial Reporter CountryUK
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Importer
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 02/10/2023
Report Date (Section F) 02/09/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number20161420-1
Device Catalogue Number20161420-1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Hospital
Date Report to Manufacturer02/09/2023
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date02/10/2023
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient SexUnknown
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