MAUDE Adverse Event Report: STRYKER-COMMUNICATIONS PKG, VISUM LED 2 SURGICAL LIGHT CAMERA READY, LC; LIGHT, SURGICAL, CEILING MOUNTED

Model Number 0682400138

Device Problem Off-Label Use (1494)

Patient Problem Burn(s) (1757)

Event Date 10/20/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that a patient returned with a burn a period of time after completion of a medical procedure in which 3 overlapping stryker visum led lights were used.Additional plastic surgery was needed to address the burn.In the stryker user manual, use of no more than two lights overlapping is recommended.During design, the temperature of surfaces lighted by our surgical light is considered through total irradiance measurements.Stryker led lights are compliant with iec60601-2-41, the medical electrical safety standard that describes the basic safety and essential performance of surgical lights and verified by a third party facility.This standard requires that: the total irradiance of a single light does not exceed 1000w/m2.As explained in our user manual, based on laboratory testing, the visum led light measures at less than or equal to 550 w/m2.The ratio of irradiance and illuminance shall not exceed 6mw/m2*lux as explained in our user manual, based on laboratory testing, the visum led light measured at less than or equal to 3.3mw/m2*lux.Additionally, the lights were tested on site and exhibited normal characteristics of visum led lights.The root case is the overlapping of more than two lights, which is off label use.

Event Description

It was reported a patient burn occurred in operating room 14.Injury sustained required additional surgical intervention.

• Brand Name: PKG, VISUM LED 2 SURGICAL LIGHT CAMERA READY, LC
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): STRYKER-COMMUNICATIONS; 571 silveron blvd; flower mound TX 75028
• Manufacturer (Section G): STRYKER-COMMUNICATIONS; 571 silveron blvd; flower mound TX 75028
• Manufacturer Contact: kimberly lynch ; 571 silveron blvd; flower mound, TX 75028 ; 9724107100
• MDR Report Key: 13174926
• MDR Text Key: 283389027
• Report Number: 0002031963-2022-00001
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 07613327054422
• UDI-Public: 07613327054422
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 0682400138
• Device Catalogue Number: 0682400138
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2021
• Initial Date FDA Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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