CUTTING LOOP, BIPOLAR 27040GP130-S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-01-22 for CUTTING LOOP, BIPOLAR 27040GP130-S manufactured by Karl Storz Se & Co. Kg.

Event Text Entries

[188078853] This is a single use electrode. The electrode was discarded by the facility and therefore, could not be evaluated.
Patient Sequence No: 1, Text Type: N, H10


[188078854] Allegedly per the customer, during a urology procedure, the electrode broke off inside the patient. The broken part of the electrode was safely removed with no harm to the patient. The electrode was replaced and the procedure completed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610617-2020-00009
MDR Report Key9616174
Report SourceUSER FACILITY
Date Received2020-01-22
Date of Report2020-01-21
Date Mfgr Received2020-01-06
Device Manufacturer Date2019-06-01
Date Added to Maude2020-01-22
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 90245
Manufacturer CountryUS
Manufacturer Postal90245
Manufacturer Phone4242188201
Manufacturer G1KARL STORZ SE & CO.KG
Manufacturer StreetDR.-KARL-STORZ -STRASSE 34 78532
Manufacturer CityTUTTLINGEN, GM,
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCUTTING LOOP, BIPOLAR
Generic NameBIPOLAR SINGLE USE CUTTING LOOP
Product CodeFAS
Date Received2020-01-22
Model Number27040GP130-S
Catalog Number27040GP130-S
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerKARL STORZ SE & CO. KG
Manufacturer AddressDR.-KARL-STORZ-STRASSE 34 78532 TUTTLINGEN, GM,


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-01-22

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