ACMI RIGID CYSTOSCOPE E-117-S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-04 for ACMI RIGID CYSTOSCOPE E-117-S manufactured by Unk.

MAUDE Entry Details

Report NumberMW5089596
MDR Report Key8966016
Date Received2019-09-04
Date of Report2019-09-03
Date of Event2019-08-19
Date Added to Maude2019-09-05
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 1

Brand NameACMI RIGID CYSTOSCOPE
Generic NameCYSTOSCOPE AND ACCESSORIES, FLEXIBLE / RIGID
Product CodeFAJ
Date Received2019-09-04
Model NumberE-117-S
Catalog NumberE-117-S
Lot NumberNONE
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK

Device Sequence Number: 2

Brand NameACMI RIGID CYSTOSCOPE
Generic NameCYSTOSCOPE AND ACCESSORIES, FLEXIBLE / RIGID
Product CodeFAJ
Date Received2019-09-04
Model NumberE-121-S
Catalog NumberE-121-S
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK

Device Sequence Number: 3

Brand NameACMI RIGID CYSTOSCOPE
Generic NameCYSTOSCOPE AND ACCESSORIES, FLEXIBLE / RIGID
Product CodeFAJ
Date Received2019-09-04
Model NumberE-123-S
Catalog NumberE-123-S
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No3
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK

Device Sequence Number: 4

Brand NameACMI RIGID CYSTOSCOPE
Generic NameCYSTOSCOPE AND ACCESSORIES, FLEXIBLE / RIGID
Product CodeFAJ
Date Received2019-09-04
Catalog NumberE-125-S
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No4
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-09-04

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