MAUDE Adverse Event Report: BERCHTOLD GMBH & CO. KG LIGHT HEAD D 660 AC; CEILING MOUNTED SURGICAL LIGHT

Catalog Number 81036

Device Problems Labelling, Instructions for Use or Training Problem (1318); Energy Output Problem (1431)

Patient Problem Burn(s) (1757)

Event Date 05/20/2015

Event Type  Injury  

Manufacturer Narrative

It was reported that the light was reported to allegedly have been the source of 2nd degree burn on a child.Through investigation by a stryker technician, it was determined that both lights were focused on the surgical site.The user manual provided to the customer warns "the overlay of the light fields can cause an increases in heat generation".Also, one of the light's lux was set higher by the customer, than manufacturer specification.The root cause was determined to be user error.

Event Description

It was reported that the light was reported to allegedly have been the source of 2nd degree burn on a child.Due to the alleged injury from the lights, stryker will investigate and file a mdr.

Manufacturer Narrative

There has been corrected data updates made to the following fields: adverse event/product problem, outcomes attributed to ae, manufacturer entity, reporting entity, manufacturing site for devices, reporting contact, clinical signs code grid, health impact code grid, component code grid, device code grid, method code grid, results code grid, and conclusion code grid.

Event Description

It was reported that the light was reported to allegedly have been the source of 2nd degree burn on a child.Due to the alleged injury from the lights, stryker will investigate and file a mdr.

• Brand Name: LIGHT HEAD D 660 AC
• Type of Device: CEILING MOUNTED SURGICAL LIGHT
• Manufacturer (Section D): BERCHTOLD GMBH & CO. KG; ludwigstaler strasse 25; tuttlingen SC 78532 ; GM 78532
• MDR Report Key: 5029436
• MDR Text Key: 24045173
• Report Number: 0001220865-2015-00002
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Followup
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 81036
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/27/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other