ENDO CLINCH* II 5MM INSTRUMENT 174317

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-14 for ENDO CLINCH* II 5MM INSTRUMENT 174317 manufactured by Covidien, Formerly Ussc Puerto Rico Inc.

Event Text Entries

[25929954] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[25929955] According to the reporter, during a lap chole, the jaw of the endo clinch ii broke and became loose. The sample will not be returned because it was not decontaminated. No surgical time was extended and no harm to patient, no blood loss of more than 500cc. The doctor opened another endo clinch ii and continued with the procedure. No part of the device fell into the body cavity. The device was not reprocessed or re-sterilised prior to its usage.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2647580-2015-00647
MDR Report Key5075563
Date Received2015-09-14
Date of Report2015-09-07
Date of Event2015-09-07
Date Mfgr Received2015-09-07
Device Manufacturer Date2014-12-01
Date Added to Maude2015-09-14
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 ContactSHARON MURPHY
Manufacturer Street60 MIDDLETOWN AVE
Manufacturer CityNORTH HAVEN CT 06473
Manufacturer CountryUS
Manufacturer Postal06473
Manufacturer Phone2034925267
Manufacturer G1COVIDIEN, FORMERLY USSC PUERTO RICO INC
Manufacturer StreetBUILDING 911-67 SABANETAS INDUSTRIAL PARK
Manufacturer CityPONCE PR 00731
Manufacturer CountryUS
Manufacturer Postal Code00731
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameENDO CLINCH* II 5MM INSTRUMENT
Generic NameFORCEPS, OBSTETRICAL
Product CodeHAD
Date Received2015-09-14
Model Number174317
Catalog Number174317
Lot NumberP4M0166X
Device Expiration Date2019-12-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN, FORMERLY USSC PUERTO RICO INC
Manufacturer AddressBUILDING 911-67 SABANETAS INDUSTRIAL PARK PONCE PR 00731 US 00731


Patients

Patient NumberTreatmentOutcomeDate
10 2015-09-14

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.