VISISTAT 35R 6/BOX 528135

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-10 for VISISTAT 35R 6/BOX 528135 manufactured by Teleflex Medical.

Event Text Entries

[182739081] (b)(4). The device history review for the product visistat 35r 6/box lot #73b1900439 investigation did not show issues related to the complaint. The device has not been returned for investigation. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10


[182739082] It was reported that the fired staples were not properly formed. A new unit was used instead to complete the procedure in the end, however, the same issue occurred to 18 staplers in total.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003898360-2020-00255
MDR Report Key9810955
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2020-03-10
Date of Report2020-02-26
Date of Event2020-01-29
Date Mfgr Received2020-02-26
Device Manufacturer Date2019-02-18
Date Added to Maude2020-03-10
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 ContactEFFIE JEFFERSON
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9194332672
Manufacturer G1TELEFLEX MEDICAL
Manufacturer StreetRANCHO EL DESCANSO
Manufacturer CityTECATE 21478
Manufacturer CountryMX
Manufacturer Postal Code21478
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVISISTAT 35R 6/BOX
Generic NameSTAPLE, REMOVABLE (SKIN)
Product CodeGDT
Date Received2020-03-10
Catalog Number528135
Lot Number73B1900439
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressMORRISVILLE NC


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-10

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