DUROGRIP NEEDLE HOLDER STR.D:5/310MM PL407R

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 2018-12-20 for DUROGRIP NEEDLE HOLDER STR.D:5/310MM PL407R manufactured by Aesculap Ag.

Event Text Entries

[131126822] (b)(4). Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10


[131126823] It was reported that a mechanism of the needle holder broke during surgery. During an unknown procedure, when the suture was placed, an internal mechanism of the durogrip needle holder broke. This issue created a surgical delay of 30 minutes. Additional details have been requested but not yet provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610612-2018-00597
MDR Report Key8187224
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-12-20
Date of Report2018-12-20
Date of Event2018-11-01
Date Facility Aware2018-12-12
Date Mfgr Received2018-11-01
Device Manufacturer Date2018-01-01
Date Added to Maude2018-12-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 NameDUROGRIP NEEDLE HOLDER STR.D:5/310MM
Generic NameINSTRUMENTS
Product CodeHXK
Date Received2018-12-20
Returned To Mfg2018-12-10
Model NumberPL407R
Catalog NumberPL407R
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Age10 MO
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerAESCULAP AG
Manufacturer AddressPO BOX 40 TUTTLINGEN, 78501 GM 78501


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-12-20

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