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

Model Number CH00000001

Device Problem Material Separation (1562)

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

Event Date 12/13/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that the blue dome separated from an f generation light.There was no patient involvement, no injuries, no adverse consequences or delay.Per rsk (b)(4) revision p, the severity is s0.If any further information is obtained, a supplemental will be filed.

Event Description

It was reported an or 9 blue dome has come off of the light head.There were no reported injuries or adverse consequences.

Event Description

It was reported an or 9 blue dome has come off of the light head.There were no reported injuries or adverse consequences.

Manufacturer Narrative

[supplemental 001] the device was evaluated and the serial number was confirmed within scope of pfa1937561 and was handled accordingly.Field h3 has been updated with 'yes' device was evaluated.Field d4 has been updated with the serial number.Field h9 has been updated with the correction/removal rpt number.

• 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
• 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: 13233178
• MDR Text Key: 294036313
• Report Number: 0008010153-2022-00001
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 07613327296167
• UDI-Public: 07613327296167
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2022

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
• Device Model Number: CH00000001
• Device Catalogue Number: CH00000001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2021
• Initial Date FDA Received: 01/11/2022
• Supplement Dates Manufacturer Received: 12/13/2021
• Supplement Dates FDA Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: RES 83355
• Patient Sequence Number: 1