MAUDE Adverse Event Report: BERCHTOLD GMBH & CO. KG LIGHTHEAD F628; LIGHT, SURGICAL, CEILING MOUNTED

Catalog Number 83171

Device Problems Mechanical Problem (1384); Material Separation (1562)

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

Event Date 08/03/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that the blue dome separated from an f generation light.The light head reported is within the scope of (b)(4) and will be handled accordingly.There was no reported patient involvement, no injuries, no adverse consequences or delay.Per (b)(4), the severity is s0.

Event Description

It was reported the blue domes in ors 9, 6, and 2 have fallen off and the back of the light electronics are showing.There were no reported injuries or adverse consequences.

Manufacturer Narrative

[supplemental 001] fields h6 for device code and conclusion code grids were updated.

Event Description

It was reported the blue domes in ors 9, 6, and 2 have fallen off and the back of the light electronics are showing.There were no reported injuries or adverse consequences.

• Brand Name: LIGHTHEAD F628
• 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: 13261466
• MDR Text Key: 288821728
• Report Number: 0008010153-2022-00003
• Device Sequence Number: 1
• Product Code: FSY
• 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: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 83171
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2021
• 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