MAUDE Adverse Event Report: STRYKER-COMMUNICATIONS PACKAGE, VISUM LED 2 SURGICAL LIGHT, CAMERA READY

Catalog Number 0682001253

Device Problem Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Date 02/10/2016

Event Type  Injury  

Manufacturer Narrative

A stryker field service technician (sfst) went to the site and measured the lux values of the individual lights.The lux readings of each light individually was below 160 klux which is within the acceptable range per ul 60601-2-41 and the user manual, 1004400185 revision u section 11.4.Additionally, the sfst was informed that all three lights were focused on the same spot during use.When focused on the same spot the lux reading was 363 klux.During use 3 led lights were overlapped and caused heat generation.The user manual (1004-400-185) for the led lights warns against overlapping the lights as this will cause heat generation.Each light meets the specification called out by the user manual.The heat generation is from customer misuse of the product.

Event Description

It was reported that the led lights get hot during cases and allegedly burned two patients.Due to the alleged burns of patients, 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, reporting contact, component code grid, clinical signs code grid, health impact code grid, method code, results code, and conclusion code.

Event Description

It was reported that the led lights get hot during cases and allegedly burned two patients.Due to the alleged burns of patients, stryker will investigate and file a mdr for each light head.

• Brand Name: PACKAGE, VISUM LED 2 SURGICAL LIGHT, CAMERA READY
• Type of Device: SURGICAL LIGHT
• Manufacturer (Section D): STRYKER-COMMUNICATIONS; 1410 lakeside parkway #100; flower mound TX 75028
• MDR Report Key: 5488901
• MDR Text Key: 39976063
• Report Number: 0002031963-2016-00004
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• 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: 03/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0682001253
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/10/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other