YANKAUER SUCTION CANNULA 2.0MM 285MM GF944R

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 2020-03-27 for YANKAUER SUCTION CANNULA 2.0MM 285MM GF944R manufactured by Aesculap Ag.

Event Text Entries

[186211720] 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


[186211721] It was reported that there was an issue with yankauer suction cannula. According to the complaint description, the customer inspected the suctions from the surgical instruments consignment cabinet; a bore camera was used for examination and metal shavings were found inside both cannulas. There was no patient harm. This incident did not occur in surgery. Additional information has been requested but not yet received as of this report. The malfunction is filed under aag reference (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610612-2020-00040
MDR Report Key9889535
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-27
Date of Report2020-03-27
Date of Event2020-03-09
Date Mfgr Received2020-03-10
Date Added to Maude2020-03-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS KERSTIN ROTHWEILER
Manufacturer StreetPO BOX 40
Manufacturer CityTUTTLINGEN, 78501
Manufacturer CountryGM
Manufacturer Postal78501
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 NameYANKAUER SUCTION CANNULA 2.0MM 285MM
Generic NameSUCTION CANNULAE
Product CodeGCX
Date Received2020-03-27
Returned To Mfg2020-03-17
Model NumberGF944R
Catalog NumberGF944R
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerAESCULAP AG
Manufacturer AddressPO BOX 40 TUTTLINGEN, 78501 GM 78501


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-27

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