CYSTOSCOPE-URETHROSCOPE SHEATH 27026BA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-01-31 for CYSTOSCOPE-URETHROSCOPE SHEATH 27026BA manufactured by Karl Storz Se & Co. Kg.

Event Text Entries

[134871177] The device has not been returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10


[134871178] Allegedly, during a cystoscopy procedure, the distal tip of the sheath came off into the patient. The piece was retrieved. There was no harm to patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610617-2019-00017
MDR Report Key8295085
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2019-01-31
Date of Report2019-01-04
Date of Event2019-01-04
Date Mfgr Received2019-01-04
Device Manufacturer Date2005-03-01
Date Added to Maude2019-01-31
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 ContactMRS. SUSIE CHEN
Manufacturer Street2151 E. GRAND AVENUE
Manufacturer CityEL SEGUNDO CA 902455017
Manufacturer CountryUS
Manufacturer Postal902455017
Manufacturer Phone4242188201
Manufacturer G1KARL STORZ SE & CO. KG
Manufacturer StreetDR.-KARL-STORZ-STRASSE 34 78532
Manufacturer CityTUTTLINGEN,
Manufacturer CountryGM
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCYSTOSCOPE-URETHROSCOPE SHEATH
Generic NameCYSTOSCOPY SHEATH
Product CodeODB
Date Received2019-01-31
Model Number27026BA
Catalog Number27026BA
Lot NumberCE
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerKARL STORZ SE & CO. KG
Manufacturer AddressDR.-KARL-STORZ-STRASSE 34 78532 TUTTLINGEN, GM


Patients

Patient NumberTreatmentOutcomeDate
10 2019-01-31

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