MULTIFIRE ENDO HERNIA 174027

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 2020-03-31 for MULTIFIRE ENDO HERNIA 174027 manufactured by Us Surgical Puerto Rico.

Event Text Entries

[185958790] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185958791] According to the reporter, when the device was used to close the mesenteric defect during a laparoscopic gastric bypass, the staple came out without correctly folding and the two staples were fired at the same time causing it to jam. A reload was also fired and this problem occluded again. Another device was used to complete the case. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2647580-2020-01156
MDR Report Key9908338
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-10
Date Mfgr Received2020-03-12
Device Manufacturer Date2019-09-11
Date Added to Maude2020-03-31
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 HEALTH CARE PROFESSIONAL
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 NameMULTIFIRE ENDO HERNIA
Generic NameLAPAROSCOPE, GENERAL & PLASTIC SURGERY
Product CodeGCJ
Date Received2020-03-31
Returned To Mfg2020-03-20
Model Number174027
Catalog Number174027
Lot NumberP9J0517Y
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerUS SURGICAL PUERTO RICO
Manufacturer Address201 SABANETAS INDUSTRIAL PARK PONCE PR 007164401 US 007164401


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.