AUTOSUTURE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-28 for AUTOSUTURE manufactured by Unk.

Event Text Entries

[93221745] Staples did not deploy from autosuture device.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5073596
MDR Report Key7063930
Date Received2017-11-28
Date of Report2017-11-22
Date of Event2016-12-07
Date Added to Maude2017-11-28
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameAUTOSUTURE
Generic NameENDO GIA STAPLE 45 2.0
Product CodeNLL
Date Received2017-11-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK


Patients

Patient NumberTreatmentOutcomeDate
10 2017-11-28

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