PURSTRING 020730

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 2018-02-20 for PURSTRING 020730 manufactured by Us Surgical Puerto Rico.

Event Text Entries

[100553437] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[100553438] According to the reporter, prior to using the device for an esophagojejunostomy anastomosis in total gastrectomy procedure, the thre ad had already broken. The case was completed using another device. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5


[118890759] Investigation summary post market vigilance (pmv) led an evaluation of one device. The visual inspection of the returned product noted that the pushers are fully deployed. Cartridges are properly seated after firing. No visual abnormalities. The condition of the device precludes functional testing. 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. Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate. 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 Number2647580-2018-00861
MDR Report Key7283407
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2018-02-20
Date of Report2018-03-09
Date of Event2018-01-24
Date Mfgr Received2018-02-21
Device Manufacturer Date2015-06-22
Date Added to Maude2018-02-20
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 Phone2034925267
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 NamePURSTRING
Generic NameCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY
Product CodeGDJ
Date Received2018-02-20
Returned To Mfg2018-02-12
Model Number020730
Catalog Number020730
Lot NumberP5F0614X
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 2018-02-20

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