DAVIS BRAIN SPATULA MALL 178X26MM MD116

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-28 for DAVIS BRAIN SPATULA MALL 178X26MM MD116 manufactured by Aesculap Inc.

Event Text Entries

[182147099] Manufacturing site evaluation: additional information / investigation results will be provided in a supplemental report. Investigation on-going, if available.
Patient Sequence No: 1, Text Type: N, H10


[182147100] It was reported that there was an issue with the davis spatulas. During cranial surgery, the spatulas were not holding shape well enough to retract the brain tissue. This involved a set of spatulas. The procedure was completed with an additional set of retractors. There was no patient harm. Associated medwatches: 2916714-2020-00029, 2916714-2020-00030, 2916714-2020-00031, 2916714-2020-00032, 2916714-2020-00033, 2916714-2020-00034.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2916714-2020-00031
MDR Report Key9638996
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-01-28
Date of Report2020-02-24
Date of Event2020-01-23
Date Mfgr Received2020-02-07
Date Added to Maude2020-01-28
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. LINDSAY CHROMIAK
Manufacturer Street3773 CORPORATE PARKWAY
Manufacturer CityCENTER VALLEY, PA PA 18034
Manufacturer CountryUS
Manufacturer Postal18034
Manufacturer G1AESCULAP INC
Manufacturer Street3773 CORPORATE PARKWAY
Manufacturer CityCENTER VALLEY, PA PA 18034
Manufacturer CountryUS
Manufacturer Postal Code18034
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDAVIS BRAIN SPATULA MALL 178X26MM
Generic NameINSTRUMENTS FOR NEUROSURGERY
Product CodeHOA
Date Received2020-01-28
Model NumberMD116
Catalog NumberMD116
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerAESCULAP INC
Manufacturer Address3773 CORPORATE PARKWAY CENTER VALLEY, PA PA 18034 US 18034


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-28

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