STERILE 3.5 SOFT KOH-EFF AD750SC-KE35

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-06 for STERILE 3.5 SOFT KOH-EFF AD750SC-KE35 manufactured by Coopersurgical, Inc..

Event Text Entries

[136994953] Coopersurgical, inc. Is currently investigating the reported complaint condition. Once the investigation is completed a follow up report will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[136994954] (b)(4). Coopersurgical has determined the condition reported (on (b)(6) 2018) : "this was sample product that was used in a case this morning at medical city plano. Upon completion of the case, it was discovered that the cup had been damaged during colpotomy stage of procedure. Surgeon stayed superficial to tissue during colpotomy using mono-polar robotic scs, however melting/lacerations to cup must have occurred when sc tips made contact with cup. No patient injury, and nothing was deposited or left in patient. " to be a reportable malfunction, based on the cumulative investigation of this failure mode on- (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1216677-2019-00016
MDR Report Key8311305
Date Received2019-02-06
Date of Report2019-02-06
Date of Event2018-09-12
Date Mfgr Received2018-09-17
Device Manufacturer Date2018-09-10
Date Added to Maude2019-02-06
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 ContactMR. PETER NIZIOLEK
Manufacturer Street50 CORPORATE DRIVE
Manufacturer CityTRUMBULL CT 06611
Manufacturer CountryUS
Manufacturer Postal06611
Manufacturer Phone2036015200
Manufacturer G1COOPERSURGICAL, INC,
Manufacturer Street75 CORPORATE DRIVE
Manufacturer CityTRUMBULL CT 06611
Manufacturer CountryUS
Manufacturer Postal Code06611
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameSTERILE 3.5 SOFT KOH-EFF
Generic NameSTERILE 3.5 SOFT KOH-EFF
Product CodeHEW
Date Received2019-02-06
Model NumberAD750SC-KE35
Catalog NumberAD750SC-KE35
Lot Number227-18
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCOOPERSURGICAL, INC.
Manufacturer Address95 CORPORATE DRIVE TRUMBULL CT 06611 US 06611


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-02-06

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