ENDO GRASP* 5MM INSTRUMENT 173030

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2016-06-13 for ENDO GRASP* 5MM INSTRUMENT 173030 manufactured by Covidien, Formerly Ussc Puerto Rico Inc.

Event Text Entries

[47227969] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[47227970] According to the reporter, during a myomectomy, one sheet of the jaw of the instrument was broken. One piece of the jaw fall into the cavity, the doctor use another endo grasp to retrieve the piece of the jaw.
Patient Sequence No: 1, Text Type: D, B5


[51351985]
Patient Sequence No: 1, Text Type: N, H10


[61916844] (b)(4). Post market vigilance (pmv)and engineering led an evaluation of one device opened by the account. This 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, an engineering evaluation, and an evaluation of the returned device. One of the jaws was disengaged from the device. A review of the device history record indicates this device lot number was released meeting all medtronic quality release specifications at the time of manufacture. Replication of damaged disengaged jaw condition may occur due to extreme handling during the application, as when too much force and excessive leverage is applied. Based on the product analysis, the failure was confirmed to be attributed to the reported event. Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2647580-2016-00317
MDR Report Key5720257
Report SourceFOREIGN,USER FACILITY
Date Received2016-06-13
Date of Report2016-06-02
Date of Event2016-06-01
Date Mfgr Received2016-11-11
Device Manufacturer Date2015-03-01
Date Added to Maude2016-06-13
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 GRASP* 5MM INSTRUMENT
Generic NameFORCEPS, OBSTETRICAL
Product CodeHAD
Date Received2016-06-13
Returned To Mfg2016-07-25
Model Number173030
Catalog Number173030
Lot NumberP5C1051X
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 2016-06-13

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