KOH-EFFICIENT,RUMI,3.0CM KC-RUMI-30

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 2019-11-25 for KOH-EFFICIENT,RUMI,3.0CM KC-RUMI-30 manufactured by Coopersurgical, Inc..

Event Text Entries

[175188171] Coopersurgical inc. Is currently investigating the reported complaint condition.
Patient Sequence No: 1, Text Type: N, H10


[175188172] "rumi cup was melted while using harmonic scalpel during lap hyst causing retained fragments. " ref: (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1216677-2019-00304
MDR Report Key9370404
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-11-25
Date of Report2020-02-13
Date of Event2019-10-31
Date Mfgr Received2019-11-06
Device Manufacturer Date2019-02-15
Date Added to Maude2019-11-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. PETER NIZIOLEK
Manufacturer Street50 CORPORATE DRIVE
Manufacturer CityTRUMBULL, DE DE 06611
Manufacturer CountryUS
Manufacturer Postal06611
Manufacturer Phone2036015200
Manufacturer G1COOPERSURGICAL, INC.
Manufacturer Street75 CORPORATE DRIVE
Manufacturer CityTRUMBULL, CT CT 06611
Manufacturer CountryUS
Manufacturer Postal Code06611
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameKOH-EFFICIENT,RUMI,3.0CM
Generic NameKOH-EFFICIENT,RUMI,3.0CM
Product CodeHEW
Date Received2019-11-25
Model NumberKC-RUMI-30
Catalog NumberKC-RUMI-30
Lot Number264970
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCOOPERSURGICAL, INC.
Manufacturer Address95 CORPORATE DRIVE TRUMBULL, CT CT 06611 US 06611


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-11-25

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