MAUDE Adverse Event Report: BERCHTOLD CHROMOPHARE; CEILING MOUNTED SURGICAL LIGHT

Model Number 660

Device Problem Use of Device Problem (1670)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 09/16/2014

Event Type  Injury  

Event Description

It was reported that during a ureteral pyeloureterostomy surgical procedure, a patient (baby), was allegedly burned while two lights were focused on the surgical site.The patient was referred to dermatology and it was determined that the patient received a 2nd degree burn.The patient was treated with silvadene 1 percent cream and was advised to continue that treatment twice daily.

Manufacturer Narrative

It was reported that during a ureteral pyeloureterostomy surgical procedure, a patient (baby), was burned while two lights were focused on the surgical site.Through investigation between the customer and berchtold service technician, it was determined that both lights were focused on the surgical site, the intensity was at it's highest, the light spot was about 6 inches and the health care professionals did not review the user manual.The user manual provided to the customer warns "the overlay of the light fields can cause an increase in heat generation".The root cause was determined to be user error.

• Brand Name: CHROMOPHARE
• Type of Device: CEILING MOUNTED SURGICAL LIGHT
• Manufacturer (Section D): BERCHTOLD; charleston SC
• Manufacturer Contact: chris mannarino ; 1950 hannahan road; charleston, SC 29406 ; 8435696100
• MDR Report Key: 4162845
• MDR Text Key: 4785330
• Report Number: 1220865-2014-00005
• Device Sequence Number: 1
• Product Code: FQP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 660
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 MO