FDA Adverse Event Injury Summary report: N

SLIM LINE EZ SURGICAL FIBER

MDR report key: 2883205 · Received December 21, 2012

Report

Report Number: 3004135191-2012-00066
Event Type: Injury
Date Received: December 21, 2012
Date of Event: November 16, 2012
Report Date: December 20, 2012
Manufacturer: LUMENIS, LTD.
Product Code: GEX
PMA / PMN Number: K011703
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CO, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

A REVIEW BY A LUMENIS TECHNICAL SPECIALIST OF LABELING FOR THE SD WAS COMPLETED AND NO DEVIATION FROM SPECIFICATIONS WAS NOTED. THE DHR (AND/OR EQUIVALENT TEST DATA) WAS REVIEWED AND NO DEVIATION FROM THE DESIGN SPECIFICATION WAS OBSERVED. REASONABLE ATTEMPTS WERE MADE TO OBTAIN THE SUBJECT DEVICE FROM THE USER FACILITY HOWEVER, THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, NO PHYSICAL EXAMINATION OF THE SUBJECT DEVICE COULD BE PERFORMED. AN EVALUATION OF THE REPORTED EVENT DETAILS BY A LUMENIS TECHNICAL SPECIALIST DETERMINED THE PROBABLE ROOT CAUSE TO BE EXCESSIVE BENDING FORCES APPLIED UNDER POWER IN CONTRADICTION TO PRODUCT LABELING. DEVICE NOT RETURNED TO MANUFACTURER.

Description of Event or Problem · 1

IT WAS REPORTED THAT A SCRUB NURSE SUSTAINED A SMALL 3MM BURN TO THE PALM OF THE HAND AS A RESULT OF A FIBER BREAK. THE DEVICE IS REPORTED TO HAVE BEEN A LUMENIS SLIMLINE FIBER; HOWEVER, THE FIBER WAS NOT RETURNED. THE INITIAL REPORTER STATED THAT THE SCRUB NURSE WAS ATTENDED BY THE FACILITY'S EMPLOYEE HEALTH DEPARTMENT AND THAT "THERE WAS NO NEED FOR FURTHER TREATMENT." MEDICAL INTERVENTION WAS REPORTEDLY NOT REQUIRED TO PRECLUDE PERMANENT IMPAIRMENT. NO PATIENT HARM WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SLIM LINE EZ SURGICAL FIBER	LASER FIBER DELIVERY DEVICE ACCESSORY	GEX	LUMENIS, LTD.	EZ SIS	0046240511

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other