KOH-EFFICIENT,RUMI,3.5CM KC-RUMI-35

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-12 for KOH-EFFICIENT,RUMI,3.5CM KC-RUMI-35 manufactured by Coopersurgical, Inc..

Event Text Entries

[111441384] Coopersurgical, inc. Is currently investigating the reported condition. Once the investigation is complete, a follow up report will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[111441385] Medwatch mw5077295. "a couple of very small pieces of the blue coating on the rumi cup were found to have come off the device and were in the patient's abdomen during a robotic assisted total laparoscopic hysterectomy. The pieces were retrieved and the device removed from the patient. No adverse effects were noted and the patient was discharged home later that day. "
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1216677-2018-00028
MDR Report Key7593317
Date Received2018-06-12
Date of Report2018-06-12
Date of Event2018-05-10
Device Manufacturer Date2018-02-20
Date Added to Maude2018-06-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. PETER NIZIOLEK
Manufacturer Street75 CORPORATE DR
Manufacturer CityTRUMBULL CT 06611
Manufacturer CountryUS
Manufacturer Postal06611
Manufacturer Phone2036015200
Manufacturer G1COOPERSURGICAL, INC.
Manufacturer Street75 CORPORATE DR
Manufacturer CityTRUMBULL CT 06611
Manufacturer CountryUS
Manufacturer Postal Code06611
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameKOH-EFFICIENT,RUMI,3.5CM
Generic NameKOH-EFFICIENT,RUMI,3.5CM
Product CodeHEW
Date Received2018-06-12
Model NumberKC-RUMI-35
Catalog NumberKC-RUMI-35
Lot Number243276
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOOPERSURGICAL, INC.
Manufacturer Address95 CORPORATE DRIVE TRUMBULL CT 06611 US 06611


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-06-12

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