VERSAJET EXACT ASSY, 45 DEGREE X 14MM 66800041

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 2020-02-06 for VERSAJET EXACT ASSY, 45 DEGREE X 14MM 66800041 manufactured by Smith & Nephew Medical Ltd..

Event Text Entries

[178360086] It was reported that during treatment the cable broke loose and there was a high-pressure leak. A backup was available but there was a delay longer than 30 minutes with the patient under anesthesia. There was no harm to the patient reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8043484-2020-00089
MDR Report Key9676799
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-02-06
Date of Report2020-02-06
Date of Event2020-01-21
Date Mfgr Received2020-01-21
Date Added to Maude2020-02-06
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 ContactDR SARAH FREESTONE
Manufacturer Street101 HESSLE ROAD
Manufacturer CityHULL HU3 2BN
Manufacturer CountryUK
Manufacturer PostalHU3 2BN
Manufacturer Phone0447940038
Manufacturer G1SMITH & NEPHEW MEDICAL LTD.
Manufacturer Street101 HESSLE ROAD
Manufacturer CityHULL HU3 2BN
Manufacturer CountryUK
Manufacturer Postal CodeHU3 2BN
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVERSAJET EXACT ASSY, 45 DEGREE X 14MM
Generic NameLAVAGE, JET
Product CodeFQH
Date Received2020-02-06
Catalog Number66800041
Lot Number50785796
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITH & NEPHEW MEDICAL LTD.
Manufacturer Address101 HESSLE ROAD HULL UK


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-06

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