ENDO DISSECT 176645

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-04-13 for ENDO DISSECT 176645 manufactured by Us Surgical Puerto Rico.

Event Text Entries

[105441183] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[105441184] According to the reporter, prior to use, the tip of the dissector was not aligning properly, not up to standard. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5


[118550712] Post market vigilance (pmv) led an evaluation of one device. Engineering verified that jaw alignment of device was within specifications. Engineering inspected jaws under a microscope and found no physical damage to the jaws. Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture. Analysis concluded there were no assembly component related failures. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2647580-2018-01832
MDR Report Key7429990
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-04-13
Date of Report2018-06-26
Date of Event2018-03-27
Date Mfgr Received2018-05-29
Device Manufacturer Date2017-01-31
Date Added to Maude2018-04-13
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 CAREGIVERS
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactLISA HERNANDEZ
Manufacturer Street60 MIDDLETOWN AVE.
Manufacturer CityNORTH HAVEN CT 06473
Manufacturer CountryUS
Manufacturer Postal06473
Manufacturer Phone2034925563
Manufacturer G1US SURGICAL PUERTO RICO
Manufacturer Street201 SABANETAS INDUSTRIAL PARK
Manufacturer CityPONCE PR 007164401
Manufacturer CountryUS
Manufacturer Postal Code007164401
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameENDO DISSECT
Generic NameMOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED
Product CodeGET
Date Received2018-04-13
Returned To Mfg2018-04-12
Model Number176645
Catalog Number176645
Lot NumberP7A1517X
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerUS SURGICAL PUERTO RICO
Manufacturer Address201 SABANETAS INDUSTRIAL PARK PONCE PR 007164401 US 007164401


Patients

Patient NumberTreatmentOutcomeDate
10 2018-04-13

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