FDA Adverse Event Injury Summary report: N

OPTILITE

MDR report key: 6306 · Received August 9, 1993

Report

Report Number: 6306
Event Type: Injury
Date Received: August 9, 1993
Date of Event: July 8, 1993
Report Date: July 14, 1993
Manufacturer: XENTEC CORPORATION
Product Code: LWX
Adverse Event: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

DR. WAS GOING TO USE FIBER FOR LAST LASE OF TISSUE, HE HAD CLEANED THE FIBER THEN REINSERTED THE FIBER INTO CYSTOSCOPE, DR. FIRED LASER 23 SECONDS THEN STOPPED, NOTICING THAT THE TIP DID NOT MOVE AS IT HAD BEFORE, AS DR. REMOVED CYSTO SCOPE AND FIBER, HE NOTIECED THAT THE TIP BROKE OFF. WHEN FIBER WAS WAS REMOVED IT WAS NOTED TO BE "CHARRED" FOR ABOUT 10 TO 12 CM. THERE WAS A SLIGHT BEND AT THE POINT WHERE THE CHARRING BEGANDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: VISUAL EXAMINATION, OTHER. RESULTS OF EVALUATION: MECHANICAL PROBLEM. CONCLUSION: USER ERROR CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OPTILITE	90 DEGREE LASER FILBER	LWX	XENTEC CORPORATION	SMA5160A	93-06-01

Patients

Seq	Age	Sex	Outcome	Treatment
1	74 YR		Required Intervention