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

Model Number CH00000001

Device Problems Temperature Problem (3022); Patient Device Interaction Problem (4001)

Patient Problem Burn(s) (1757)

Event Date 07/02/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that in wpor 1, the chromophare d650 surgical light caused a patient burn.Through further investigation the stryker field service technician (sfst) reported there were actually two chromophare d660 halogen surgical lights that burned a 3 month old who was undergoing an anorectoplasty procedure.When the sfst went to the site and inspected the surgical lights.During the functional testing it was found that the lights were operating properly.The lux readings were measured, and both lights were found to be operating within specification.It is unknown exactly how close the lights were in proximity to the patient at the time the incident occurred, and there was no reported malfunction of the lights.The cautions and warnings regarding usage of the chromophare d660 halogen surgical lights is located in the berchtold chromophare d660, d540, d510 service manual, part #57184, revision c.Section 2.2.The safety information contained in this section warns against using the lights at distances closer than 60 centimeters.Although the exact root cause of this issue is unknown, potential root causes could include lights being used closer to the patient than prescribed in the chromophare d660 service manual, lights being used in tandem, other surgical tools and equipment being used at the time of the procedure, and operator error.

Event Description

It was reported that the d650 light allegedly caused a patient burn.Due to the alleged burn of patient, stryker will investigate and file a mdr for each light head.

Event Description

It was reported that the d650 light allegedly caused a patient burn.Due to the alleged burn of patient, stryker will investigate and file a mdr for each light head.

Manufacturer Narrative

There has been corrected data updates made to the following fields: outcomes attributed to ae, clinical signs code grid, health impact code grid, and component code grid.

• 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
• MDR Report Key: 8828836
• MDR Text Key: 152472135
• Report Number: 0008010153-2019-00008
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 07613327296167
• UDI-Public: 07613327296167
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CH00000001
• Device Catalogue Number: CH00000001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other