MAUDE Adverse Event Report: WELCH ALLYN WELCH ALLYN HALOGEN EXAM LIGHT III; EXAM LT. III 35W HAL/LTBOX

Model Number 48740

Device Problem Insufficient Information (3190)

Patient Problems Burn(s) (1757); Nerve Damage (1979); Scarring (2061)

Event Date 10/12/2012

Event Type  Injury  

Event Description

Welch allyn was served with a complaint for an event that occurred in (b)(6) 2012 at a medical facility in texas.A woman is claiming that her hand was severely burned when the clinicians placed it on a hot light box during a surgery (endometrial ablation and hysteroscopy).The complaint alleges that prior to, during, and after a surgical procedure for which the plaintiff was anesthetized, the plaintiff's hand was placed on a light box source or an instrument or device in the operating room theatre which caused severe and permanent injuries to plaintiff's hand including severe burns, scarring and permanent nerve damage.

Manufacturer Narrative

The investigation is not yet complete.A f/u report will be submitted when the eval is completed.

Manufacturer Narrative

Welch allyn was able to investigate the light box, with the associated table mount and mattress at the medical facility.The review noted the light box at some point had been incorrectly mounted to be the same height as the mattress and tightly press against it, possibly resulting in blockage of the fan heat vent.Following the event, the medical facility had the light box remounted to a lower position below the mattress.Review of service records has determined that welch allyn did not mount the device.The device directions for use includes instructions for mounting, including direction to verify that the top of the mounting bracket is at least 10 inches below the table top cushion.Welch allyn performed rigorous temperature testing on a similar device with the fan blocked with no deviations or anomalies found and the results still met the required standard for the device at the time of design, and of manufacture of the lot at issue in this complaint.Review of dhr for the complaint lot shows no production issues occurred.There is no evidence that the device malfunctioned, and the design of the device met its intended use.Because the device was at some point in time incorrectly installed in such a manner as to block the fan, it is possible that the device enclosure reached a higher than normal temperature.However, there was no apparent malfunction of the light, which was found to be in good working order soon after the incident, and again during the welch allyn onsite inspection.Additionally, at the time of the event, no person at the scene witnessed the plaintiff's hand exposed to or in contact with the light box, or smelled or heard anything unusual.The patient's hands were tucked by her sides inside a blanket at the start of the procedure.It is unknown if, how and when (for how long) the patient's hand was in contact with the light box.Therefore, welch allyn cannot conclude here whether the blocked fan, resulting in an elevated temperature, would have caused this patient's burn.This is the only complaint reported that involved a burn alleged to be caused by prolonged contact with the light box, as against (b)(4) devices in the field (including (b)(4) table mount versions), and a 15 year history of use; and there is no evidence of malfunction.

• Brand Name: WELCH ALLYN HALOGEN EXAM LIGHT III
• Type of Device: EXAM LT. III 35W HAL/LTBOX
• Manufacturer (Section D): WELCH ALLYN; 4341 state st. rd.; skaneateles falls NY 13153
• Manufacturer (Section G): WELCH ALLYN; 4341 state street road; skaneateles falls NY 13153
• Manufacturer Contact: lauren neubauer ; 4341 state street road; p.o. box 220; skaneateles falls, NY 13153-0220 ; 3156853674
• MDR Report Key: 4254534
• MDR Text Key: 17260525
• Report Number: 1316463-2014-00011
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K780628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 10/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 48740
• Device Catalogue Number: 48740
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2007
• 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; Disability
• Patient Age: 40 YR