ENDO DISSECT 176645

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,user faci report with the FDA on 2018-10-23 for ENDO DISSECT 176645 manufactured by Us Surgical Puerto Rico.

Event Text Entries

[124699271] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[124699272] According to the reporter, during laparocopic gastrectomy procedure, the device tip broke with cracking sound while checking for opening and closing after removing the device from the package. The lever of the other device was too hard to operate. The procedure was completed with another device. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2647580-2018-05126
MDR Report Key7995287
Report SourceDISTRIBUTOR,FOREIGN,USER FACI
Date Received2018-10-23
Date of Report2019-02-15
Date of Event2018-09-20
Date Mfgr Received2019-01-23
Device Manufacturer Date2017-05-15
Date Added to Maude2018-10-23
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 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 Received2018-10-23
Returned To Mfg2018-11-05
Model Number176645
Catalog Number176645
Lot NumberP7E0416X
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 2018-10-23

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