CL300 SFI SURGICAL HEADLIGHT SYSTEM

Description of Event or Problem

ON (B)(6) 2010, WELCH ALLYN WAS INFORMED THAT A (B)(6) MALE PT UNDERGOING AN INGUINAL HERNIAL REPAIR PROCEDURE, ALLEGEDLY RECEIVED AN 1CM BLISTER ON HIS ABDOMEN. THE ATTENDING PHYSICIAN WAS USING A FIBER OPTIC SURGICAL HEADLIGHT SYSTEM TO ILLUMINATE THE REGION OF INTEREST ON THE PT DURING THE SURGERY. THE PT'S SKIN HAD BEEN PREPPED WITH BETADINE AND DRAPED, A SMALL PORTION OF THE ABDOMEN WAS EXPOSED AND IT WAS THIS EXPOSED AREA OF THE ABDOMEN WHERE THE BLISTER/BURN OCCURRED; BACITRACIN OINTMENT WAS APPLIED TO THE BLISTER/BURN. THE CUSTOMER DID NOT PROVIDE A PT IDENTIFIER.

Additional Manufacturer Narrative

THE CUSTOMER RETURNED THE CL300 HEADLIGHT SYSTEM TO WELCH ALLYN FOR EVAL. FUNCTIONAL AND OPTICAL TESTING, AS PERFORMED BY WELCH ALLYN, DID NOT INDICATE THAT THE CL300 WAS THE LIKELY CAUSE OF THE PT BLISTER/BURN. THE ULTRAVIOLET (UV) FILTERS WERE IN PLACE AND FUNCTIONAL. THE LAMP OUTPUT POWER WAS MEASURED AND FOUND TO BE LOW: 112 LUMENS VERSUS NEW LAMP SPECIFICATION OF 400 - 450 LUMENS AVERAGE. THE SYSTEM'S SPECTRAL OUTPUT WAS EVALUATED AND FOUND TO BE 34% OF THE CONTROL DEVICE: THE SUM OF UV (250-380 NM) POWER OF THE EVENT CL300 WAS 4 X 10-6 W/CM2, WHILE THAT OF THE CONTROL DEVICE WAS 1.3 X 10-5 W/CM2.