ENDO CLINCH II 174317

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-04-04 for ENDO CLINCH II 174317 manufactured by Us Surgical Puerto Rico.

Event Text Entries

[140902211] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[140902212] According to the reporter, when the product was prepared during laparoscopic cholecystectomy, there was a feeling of strangeness at the tip when the product was taken out from the package. After checking, the root of the jaws was found to be unsteady and was about to come off. A new product was opened and used to complete the case. The event occurred during the procedure but the product was not used for patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2647580-2019-01812
MDR Report Key8482543
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2019-04-04
Date of Report2019-06-18
Date of Event2019-03-12
Date Mfgr Received2019-05-29
Device Manufacturer Date2018-10-16
Date Added to Maude2019-04-04
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 CLINCH II
Generic NameFORCEPS, OBSTETRICAL
Product CodeHDA
Date Received2019-04-04
Returned To Mfg2019-04-03
Model Number174317
Catalog Number174317
Lot NumberP8K1505PX
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 2019-04-04

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