HF COMBI UNIT 300W MONOP.80W.BIPOLAR GN300

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-27 for HF COMBI UNIT 300W MONOP.80W.BIPOLAR GN300 manufactured by Aesculap Ag.

Event Text Entries

[71213483] (b)(4). Manufacturing site evaluation: evaluation on-going.
Patient Sequence No: 1, Text Type: N, H10


[71213484] Country of complaint: (b)(6). It was reported that the device had extreme burning issues.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610612-2017-00151
MDR Report Key6437603
Date Received2017-03-27
Date of Report2017-06-27
Date Facility Aware2017-03-09
Date Mfgr Received2017-02-24
Device Manufacturer Date2015-12-21
Date Added to Maude2017-03-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. NICOLE BROYLES
Manufacturer Street615 LAMBERT POINTE DRIVE
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer Phone3145515988
Manufacturer G1AESCULAP AG
Manufacturer StreetPO BOX 40
Manufacturer CityTUTTLINGEN, 78501
Manufacturer CountryGM
Manufacturer Postal Code78501
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHF COMBI UNIT 300W MONOP.80W.BIPOLAR
Generic NameENDOSCOPY
Product CodeKPZ
Date Received2017-03-27
Returned To Mfg2017-03-02
Model NumberGN300
Catalog NumberGN300
Lot Number52187002
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Age15 MO
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerAESCULAP AG
Manufacturer AddressPO BOX 40 TUTTLINGEN, 78501 GM 78501


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-03-27

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