ACCULAN II PISTOL-SHAPED BATTERY DRILL GA620D

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-02 for ACCULAN II PISTOL-SHAPED BATTERY DRILL GA620D manufactured by Aesculap Ag.

Event Text Entries

[76719767] Reported device not marketed in the u. S. , however, similar devices or devices that share components, raw materials, process methods or any other technological characteristics with a medical device that is registered within the u. S. (b)(4). Manufacturing site evaluation: evaluation on-going.
Patient Sequence No: 1, Text Type: N, H10


[76719768] (b)(6). It was reported that during surgery the drill continued to run and would not stop and the surgical nurse drilled into their fingers.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610612-2017-00291
MDR Report Key6609665
Date Received2017-06-02
Date of Report2017-06-27
Date Facility Aware2017-05-16
Date Mfgr Received2017-05-04
Date Added to Maude2017-06-02
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 NameACCULAN II PISTOL-SHAPED BATTERY DRILL
Generic NamePOWER SYSTEMS ORTHOPAEDICS
Product CodeNWF
Date Received2017-06-02
Returned To Mfg2017-05-05
Model NumberGA620D
Catalog NumberGA620D
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
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 2017-06-02

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