TC BABY-METZ SCISSORSDELCVDB/B145MM BC259R

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-02-05 for TC BABY-METZ SCISSORSDELCVDB/B145MM BC259R manufactured by Aesculap Ag.

Event Text Entries

[137006759] (b)(4). Investigation on-going. Additional information / investigation results will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10


[137006760] It was reported that there was an intraoperative issue with the scissors during a procedure for carpal tunnel syndrome. It broke suddenly during normal use and without unusual circumstances or force. The tissue was being spread using the baby metz scissors when the malfunction occurred; one of the sides of the handle broke off near the joint. The surgical outcome and patient data was not provided. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610612-2019-00053
MDR Report Key8306579
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-02-05
Date of Report2019-02-06
Date Facility Aware2019-02-06
Date Mfgr Received2019-02-06
Date Added to Maude2019-02-05
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 NameTC BABY-METZ SCISSORSDELCVDB/B145MM
Generic NameBASIC INSTRUMENTS
Product CodeLRW
Date Received2019-02-05
Returned To Mfg2019-01-18
Model NumberBC259R
Catalog NumberBC259R
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
10 2019-02-05

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