DENTO-SURGE DENTO-SURGE F.F.P *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-03-26 for DENTO-SURGE DENTO-SURGE F.F.P * manufactured by Ellman International Inc..

Event Text Entries

[310270] While calibrating the dento-surge, received an electric shock/burn. Rptr removed the output power control knob to attempt to re-align the knob with the proper corresponding expected output. The knob is attached to a plastic stem which is held in place by a metal sleeve connected to the plastic stem. Rptr received a shock/burn on their right thumb. Upon inspecting the unit in question rptr noticed that the metal sleeve on the output control knob is directly connected to a potentiometer "vari-capicitor as noted in the service manual. " this design is very dangerous and can present an un-wanted shock to the operator while turning the knob.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1031685
• MDR Report Key: 520420
• Date Received: 2004-03-26
• Date of Report: 2004-03-18
• Date of Event: 2004-03-16
• Date Added to Maude: 2004-04-15
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: BIOMEDICAL ENGINEER
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DENTO-SURGE
• Generic Name: HYFRECATOR
• Product Code: EKZ
• Date Received: 2004-03-26
• Model Number: DENTO-SURGE F.F.P
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 509516
• Manufacturer: ELLMAN INTERNATIONAL INC.
• Manufacturer Address: 1135 RAILROAD AVE HEWLETT NY 11557 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2004-03-26