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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BERCHTOLD GMBH & CO. KG CHROMOPHARE OR LIGHT CEILING-MOUNTED; LIGHT, SURGICAL, CEILING MOUNTED
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BERCHTOLD GMBH & CO. KG CHROMOPHARE OR LIGHT CEILING-MOUNTED; LIGHT, SURGICAL, CEILING MOUNTED Back to Search Results
Model Number CH00000001
Medical Device Problem Code Mechanical Problem (1384)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/02/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
It was reported the blue dome separated from the light head outside of a case.There was no reported patient involvement, injuries, or adverse consequences.The root cause of this is due to the lack of adhesion between the blue dome and the plastic portion of the light head cover.
 
Event or Problem Description
It was reported the or 1 blue dome cover coming off of light head.There were no reported injuries or adverse consequences.
 
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Brand Name
CHROMOPHARE OR LIGHT CEILING-MOUNTED
Common Device Name
LIGHT, SURGICAL, CEILING MOUNTED
Manufacturer (Section D)
BERCHTOLD GMBH & CO. KG
ludwigstaler strasse 25
tuttlingen 78532
GM  78532
MDR Report Key12397980
Report Number0008010153-2021-00007
Device Sequence Number4056643
Product Code FSY
UDI-Device Identifier07613327296167
UDI-Public07613327296167
Combination Product (Y/N)N
Initial Reporter StateOR
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 08/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Model NumberCH00000001
Device Catalogue NumberCH00000001
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/02/2021
Initial Report FDA Received Date08/31/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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