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 12/15/2021

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 rsk12227 revision p, the severity is s0.If any further information is obtained, a supplemental will be filed.

Event Description

It was reported the blue dome fell off from light in or 4.There were no reported injuries or adverse consequences.

Manufacturer Narrative

Device code field h6 is updated to material separation.H9 has been updated to include res number since the device is within scope of the pfa.

Event Description

It was reported the blue dome fell off from light in or 4.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: 13261469
• MDR Text Key: 287280690
• Report Number: 0008010153-2022-00005
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/14/2022

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: 12/15/2021
• 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