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 from a foreign report with the FDA on 2015-12-09 for ENDO CLINCH* II 5MM INSTRUMENT 174317 manufactured by Covidien, Formerly Ussc Puerto Rico Inc.

Event Text Entries

[33437607] (b)(4). Additional attempts to obtain information and the device have been made. A supplemental report will be submitted with new details if they become available.
Patient Sequence No: 1, Text Type: N, H10


[33437608] According to the reporter, the forceps broke when used by surgeon.
Patient Sequence No: 1, Text Type: D, B5


[33481077]
Patient Sequence No: 1, Text Type: N, H10


[33537800] .
Patient Sequence No: 1, Text Type: N, H10


[33537801] A portion of the device did fall into the patient cavity and were not retrieved from the patient.
Patient Sequence No: 1, Text Type: D, B5


[41754284] Evaluation summary: post market vigilance (pmv) received one device opened by the account with the appropriate blister package in an undamaged condition. The evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends, and an evaluation of the returned device. The jaws were found to be damaged. The rotation knob functioned properly. The jaws could not be operated and failed to open and close. The handles opened and closed without any hang ups noted. The unit was disassembled to evaluate the jaw subassembly, it was found the center rod broken. A review of the device history record indicates this device lot number was released meeting all quality release specifications at the time of manufacture. Subsequently, the complaint data did not display increased trends for the complaint. Replication of the observed conditions may occur due to excessive manipulation during application that consequently causes the breakage of the center rod. Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2647580-2015-00881
MDR Report Key5276788
Report SourceFOREIGN
Date Received2015-12-09
Date of Report2016-01-25
Date of Event2015-12-02
Date Mfgr Received2016-03-29
Device Manufacturer Date2015-06-01
Date Added to Maude2015-12-09
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 Report3

Device Details

Brand NameENDO CLINCH* II 5MM INSTRUMENT
Generic NameFORCEPS, OBSTETRICAL
Product CodeHAD
Date Received2015-12-09
Returned To Mfg2016-01-25
Model Number174317
Catalog Number174317
Lot NumberP5F0561X
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
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 2015-12-09

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