RESECTOSCOPE INNER SHEATH 28FR 27040XB

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-10 for RESECTOSCOPE INNER SHEATH 28FR 27040XB manufactured by Karl Storz Se And Co. Kg.

Event Text Entries

[145108634] Plastic tip broke off during surgery - retrieved by surgeon.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5086564
MDR Report Key8604286
Date Received2019-05-10
Date of Report2019-05-02
Date of Event2019-05-01
Date Added to Maude2019-05-13
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 NameRESECTOSCOPE INNER SHEATH 28FR
Generic NameRESECTOSCOPE
Product CodeFJL
Date Received2019-05-10
Model Number27040XB
Lot NumberPS03
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerKARL STORZ SE AND CO. KG


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-10

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