MAUDE Adverse Event Report: BERCHTOLD GMBH & CO. KG LIGHT HEAD D 660 AC; CHROMOPHARE D SERIES

Catalog Number 81036

Device Problems Labelling, Instructions for Use or Training Problem (1318); Energy Output Problem (1431); Output above Specifications (1432); Use of Device Problem (1670)

Patient Problem Burn(s) (1757)

Event Date 10/26/2015

Event Type  Injury  

Manufacturer Narrative

It was reported that the light allegedly burned a child during surgery.Through investigation by a stryker field service technician and a quality engineer, it was determined that the lights were all focused on the surgical site.The distance of the lights from the patient were measured.The user manual provided to the customer warns "the overlay of the light fields can cause an increases in heat generation".The technician inspected the three lights in the operating room where the alleged burn occurred.The lux light reading and voltage measurement for all three lights were recorded.Additional investigation is still ongoing and a supplemental mdr will be filed when the investigation is completed, if new information is available.

Event Description

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

Manufacturer Narrative

It was reported that the light allegedly may have been the source of a burn on a child.Due to the alleged injury from the lights, stryker investigated and filed a mdr.The product was not returned.The light was examined on site in the operating room.There was minimal physical damage based on visual inspection.There was evidence that the 3 light heads in the operating room (or) were positioned in a way that the light fields overlapped during the procedure.The dhr was reviewed.The light was manufactured to specification.Stryker concludes that this was a result of improper use of device.

Event Description

It was reported that the light allegedly may have been the source of a 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: outcomes attributed to ae, manufacturer entity, reporting entity, reporting contact, manufacturing site for devices, clinical signs code grid, health impact code grid, conclusion code grid, device code grid, method code grid, results code grid, and component code grid.

Event Description

It was reported that the light allegedly may have been the source of a 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: CHROMOPHARE D SERIES
• Manufacturer (Section D): BERCHTOLD GMBH & CO. KG; ludwigstaler strasse 25; tuttlingen SC 78532 ; GM 78532
• MDR Report Key: 5240724
• MDR Text Key: 31785459
• Report Number: 0001220865-2015-00005
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 81036
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/27/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other