HAND-TROL * 60-2800-501

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-08 for HAND-TROL * 60-2800-501 manufactured by Conmed Corp.

Event Text Entries

[5839686] Doctor was using cautery on patient and tip of cautery pencil broke and fell into patient surgical field then broken piece retrived. No patient harm. ======================manufacturer response for cautery hand piece (hand-trol), hand-trol (per site reporter). ======================sales rep to investigate.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number4826422
MDR Report Key4826422
Date Received2015-06-08
Date of Report2015-06-08
Date of Event2015-06-02
Report Date2015-06-08
Date Reported to FDA2015-06-08
Date Reported to Mfgr2015-06-09
Date Added to Maude2015-06-09
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameHAND-TROL
Generic NameCAUTERY PENCIL
Product CodeDWG
Date Received2015-06-08
Model Number*
Catalog Number60-2800-501
Lot Number140721-4
ID Number*
OperatorPHYSICIAN
Device AvailabilityY
Device Age1 DA
Device Sequence No1
Device Event Key0
ManufacturerCONMED CORP
Manufacturer Address525 FRENCH ROAD UTICA NY 13502 US 13502


Patients

Patient NumberTreatmentOutcomeDate
10 2015-06-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.