FDA Adverse Event Injury Summary report: N

CL300 SFI SURGICAL HEADLIGHT SYSTEM

MDR report key: 1731266 · Received June 17, 2010

Report

Report Number: 1316463-2010-00004
Event Type: Injury
Date Received: June 17, 2010
Date of Event: May 18, 2010
Report Date: May 18, 2010
Manufacturer: WELCH ALLYN
Product Code: FJC
PMA / PMN Number: K952691
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: BIOMEDICAL ENGINEER

Narratives

Additional Manufacturer Narrative · 1

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.

Description of Event or Problem · 1

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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CL300 SFI SURGICAL HEADLIGHT SYSTEM		FJC	WELCH ALLYN	90123

Patients

Seq	Age	Sex	Outcome	Treatment
1	1 MO