FDA Adverse Event Injury Summary report: N

SULFA HEXAFLUORIDE (SF6)

MDR report key: 1041331 · Received April 7, 2008

Report

Report Number: 1041331
Event Type: Injury
Date Received: April 7, 2008
Date of Event: February 28, 2008
Report Date: April 7, 2008
Manufacturer: ALCON LABORATORIES, INC.
Product Code: LPO
Adverse Event: Yes
Report Source: User Facility report
Reporter Location: KY, US

Narratives

Description of Event or Problem · 1

SURGEON PERFORMED THE FOLLOWING SURGERY DUE TO RETINAL DETACHMENT: LEFT PARS PLANA VITRECTOMY, AIR-FLUID EXCHANGE, PER FLURON, ENDO LASER, INJECTION 20% SF6 GAS. THE PATIENT PRESENTED TO SURGEON'S OFFICE FOR FOLLOW UP AND THERE WAS A RECURRENT DETACHMENT, REQUIRING ANOTHER SURGICAL PROCEDURE. ACCORDING TO THE H&P DICTATED BY MD FOR THE 2ND PROCEDURE, "ALTHOUGH THE RETINA WAS ATTACHED THE 1ST POSTOP DAY, THE DETACHMENT HAS RE-OCCURRED TEMPORALLY AS WELL AS A NEW DETACHMENT INFERIORLY AND NASALLY WITH RE-OPENING OF THE PRE-EXISTING BREAKS ALONG WITH MULTIPLE NEW BREAKS NASALLY. IT IS UNCLEAR EXACTLY WHY THE SF6 BUBBLE ABSORBED IN SUCH A BRIEF PERIOD OF TIME AS WELL AS WHY SHE DEVELOPED THE MULTIPLE NEW BREAKS. A SECOND SURGERY WAS PERFORMED 12 DAYS LATER. THIS PROCEDURE WAS: PARS PLANA SCLERAL BUCKLE (240, 250, 276, ELEMENTS), PARS PLANE LENSECTOMY, PARS PLANA VITRECTOMY, FLUID-AIR EXCHANGE, ENDOLASER PHOTOCOAGULATION AND INJECTION OF 20% C3F8 GAS, LEFT SITE.SURGEONS HAVE INDICATED THE SF6 GAS BUBBLE FROM ORIGINAL PROCEDURE DISSIPATED FASTER THAN IT SHOULD HAVE. THE BUBBLE IS NEEDED TO TAMPONADE THE DETACHMENT. WHEN GAS WAS DELIVERED TO SURGICAL FIELD, ROUTINE PROCESS WAS FOLLOWED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SULFA HEXAFLUORIDE (SF6)	OPHTHALMIC GAS, SF6	LPO	ALCON LABORATORIES, INC.	*	623308
2	VICTOR	REGULATOR, COMPRESSED GAS	CAN	VICTOR MEDICAL PRODUCTS	LB150A180	*

Patients

Seq	Age	Sex	Outcome	Treatment
1	32 YR		Other\| R