MAUDE Adverse Event Report: BERCHTOLD GMBH & CO. KG CHROMOPHARE OR LIGHT CEILING-MOUNTED; LIGHT, SURGICAL, CEILING MOUNTED

Catalog Number	CH00000001
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that report the blue cover at the top of the light came off.There were no reported injuries or adverse consequences.
Additional Manufacturer Narrative
It was reported that the blue circular dome on the back of the f gen light head fell off.There was no associated procedure, there were no reported injuries, or adverse consequences.Nc1934944, pfa1937561, capa1990175, and res 83355 were opened to review and address this issue.This light is within scope of the field action.Please note for section d4, the correct serial number is (b)(6).

• 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
• Manufacturer (Section G): BERCHTOLD GMBH & CO. KG; ludwigstaler strasse 25; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: volker hornscheidt ; ludwigstaler strasse 25; tuttlingen 78532 ; GM 78532 ; 74611810
• MDR Report Key: 17769930
• Report Number: 0008010153-2023-00018
• Device Sequence Number: 14986518
• Product Code: FSY
• UDI-Device Identifier: 07613327296167
• UDI-Public: 07613327296167
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2023

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: Other
• Device Catalogue Number: CH00000001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown