SNOWDEN-PENCER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-21 for SNOWDEN-PENCER manufactured by Carefusion.

Event Text Entries

[95527688]
Patient Sequence No: 1, Text Type: N, H10


[95527689] During endoscopic brow lift surgery, one side of the snowden-pencer endograsper broke off. The broken piece was identified and safely removed in it's entirety. There were no untoward patient effects.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number7137605
MDR Report Key7137605
Date Received2017-12-21
Date of Report2017-12-12
Date of Event2017-12-12
Report Date2017-12-12
Date Reported to FDA2017-12-12
Date Reported to Mfgr2017-12-12
Date Added to Maude2017-12-21
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Sequence Number: 0

Brand NameSNOWDEN-PENCER
Generic NameFORCEPS, GENERAL, PLASTIC
Product CodeKOG
Date Received2017-12-21
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No0
Device Event Key0
ManufacturerCAREFUSION
Manufacturer Address5 SUNNEN DR. SAINT LOUIS MO 63143 US 63143

Device Sequence Number: 1

Brand NameSNOWDEN-PENCER
Generic NameFORCEPS, GENERAL, PLASTIC
Product CodeGEN
Date Received2017-12-21
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCAREFUSION
Manufacturer Address5 SUNNEN DR. SAINT LOUIS MO 63143 US 63143


Patients

Patient NumberTreatmentOutcomeDate
10 2017-12-21

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