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

Model Number	0682400138
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/20/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 0002031963-2022-00001
• Device Sequence Number: 5934653
• Product Code: FSY
• UDI-Device Identifier: 07613327054422
• UDI-Public: 07613327054422
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2021
• Initial Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown