RESECTOSCOPE SHEATH EIS HCF25

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-04 for RESECTOSCOPE SHEATH EIS HCF25 manufactured by Olympus Medical Products Czech.

Event Text Entries

[141105323] During procedure for cystoscopy, surgeon noted plastic tip of resectoscope broke off. Surgeon was able to retrieve broken tip. No procedure complications noted and no harm to the pt. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5085596
MDR Report Key8487031
Date Received2019-04-04
Date of Report2019-04-02
Date of Event2018-07-31
Date Added to Maude2019-04-05
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Sequence Number: 0

Brand NameRESECTOSCOPE SHEATH
Generic NameRESECTOSCOPE
Product CodeFDC
Date Received2019-04-04
Model NumberEIS HCF25
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No0
Device Event Key0
ManufacturerOLYMPUS MEDICAL PRODUCTS CZECH
Manufacturer AddressUS

Device Sequence Number: 1

Brand NameRESECTOSCOPE SHEATH
Generic NameRESECTOSCOPE
Product CodeFDC
Date Received2019-04-04
Model NumberEIS HCF25
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerOLYMPUS MEDICAL PRODUCTS SZECH
Manufacturer AddressUS


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2019-04-04

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