STORZ BOWEL GRASPER INSERT 334LOC

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-25 for STORZ BOWEL GRASPER INSERT 334LOC manufactured by Karl Storz Endoscopy-america, Inc..

Event Text Entries

[185223404] One section of the bowel grasper tip broke off inside the pt. Tip was removed and x-ray was completed to ensure grasper tip was successfully removed. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093927
MDR Report Key9882873
Date Received2020-03-25
Date of Report2020-03-24
Date of Event2020-03-09
Date Added to Maude2020-03-26
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 Report3

Device Details

Brand NameSTORZ BOWEL GRASPER INSERT
Generic NameLAPAROSCOPE, GENERAL & PLASTIC SURGERY
Product CodeGCJ
Date Received2020-03-25
Model Number334LOC
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerKARL STORZ ENDOSCOPY-AMERICA, INC.


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-25

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