MAUDE Adverse Event Report: DAI-ICHI SHOMEI CO., LTD SKYTRON; SURGICAL LIGHT

Model Number ST23LH

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn, Thermal (2530)

Event Type  Injury  

Event Description

On april 28, 2015, dai-ichi shomei received information that during a leg procedure, the surgical light was 24" away from a wrapped patient's leg when the physician confirmed that the wrap was hot.The wrap was stuck to the leg skin and caused a burn or blister upon removal.

• Brand Name: SKYTRON
• Type of Device: SURGICAL LIGHT
• Manufacturer (Section D): DAI-ICHI SHOMEI CO., LTD; 32-26 sakashita; itabashi-ku; tokyo 174-0 043; JA 174-0043
• Manufacturer (Section G): DAI-ICHI SHOMEI CO., LTD; 32-26 sakashita; itabashi-ku, tokyo 174-0 043; JA 174-0043
• Manufacturer Contact: yoko yoshii ; 32-26 sakashita; itabashi-ku, tokyo 174-0-043 ; JA 174-0043
• MDR Report Key: 7734558
• MDR Text Key: 193025219
• Report Number: 3006437518-2015-00002
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• PMA/PMN Number: K002463
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: ST23LH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2015
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other