OPTILITE SMA5160A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-09 for OPTILITE SMA5160A manufactured by Xentec Corporation.

Event Text Entries

[19553337] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 6306
• MDR Report Key: 6306
• Date Received: 1993-08-09
• Date of Report: 1993-07-14
• Date of Event: 1993-07-08
• Date Facility Aware: 1993-07-08
• Report Date: 1993-07-14
• Date Reported to FDA: 1993-07-14
• Date Reported to Mfgr: 1993-07-08
• Date Added to Maude: 1993-08-30
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: OPTILITE
• Generic Name: 90 DEGREE LASER FILBER
• Product Code: LWX
• Date Received: 1993-08-09
• Model Number: SMA5160A
• Catalog Number: SMA5160A
• Lot Number: 93-06-01
• ID Number: NA
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-JUL-93
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 5995
• Manufacturer: XENTEC CORPORATION

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-08-09