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

Model Number CH00000001

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/02/2021

Event Type  malfunction  

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 Description

It was reported the or 1 blue dome cover coming off of light head.There were no reported injuries or adverse consequences.

• Brand Name: CHROMOPHARE OR LIGHT CEILING-MOUNTED
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): BERCHTOLD GMBH & CO. KG; ludwigstaler strasse 25; tuttlingen 78532 ; GM 78532
• MDR Report Key: 12397980
• MDR Text Key: 280525680
• Report Number: 0008010153-2021-00007
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 07613327296167
• UDI-Public: 07613327296167
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CH00000001
• Device Catalogue Number: CH00000001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1