SHARPLAN ULTRASONIC ASPIRATOR TIP * AA-264-6700

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-08-13 for SHARPLAN ULTRASONIC ASPIRATOR TIP * AA-264-6700 manufactured by Fibra Sonics, Inc..

Event Text Entries

[91229] It has been reported that over the course of a week, a neurosurgery department has encountered several instances of tip breakages while utilizing their ultrasonic aspirator. There has not been a report of any adverse consequence to the pt, and an investigation has been initiated, and is ongoing, to determine the cause of the situation.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1420001-1997-00005
• MDR Report Key: 113614
• Date Received: 1997-08-13
• Date of Report: 1997-08-13
• Date of Event: 1997-07-01
• Date Facility Aware: 1997-07-16
• Report Date: 1997-08-13
• Date Reported to FDA: 1997-08-13
• Date Reported to Mfgr: 1997-07-18
• Date Added to Maude: 1997-08-19
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: BIOMEDICAL ENGINEER
• Health Professional: 3
• Initial Report to FDA: 3
• 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: SHARPLAN ULTRASONIC ASPIRATOR TIP
• Generic Name: ULTRASONIC ASPIRATOR ACCESSORY
• Product Code: MGI
• Date Received: 1997-08-13
• Returned To Mfg: 1997-07-18
• Model Number: *
• Catalog Number: AA-264-6700
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: 6 MO
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 111535
• Manufacturer: FIBRA SONICS, INC.
• Manufacturer Address: 5312 NORTH ELSTON AVE. CHICAGO IL 60630 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		1997-08-13