TROCAR CATH 24FR 8888561050-

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-02-17 for TROCAR CATH 24FR 8888561050- manufactured by Covidien.

Event Text Entries

[179717845] The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product. If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Patient Sequence No: 1, Text Type: N, H10


[179717846] The customer reported the tip of the device remained in the chest of the patient. Additional information was received stating that the trocar was removed from the patient endoscopically before the start of the operation and the patient was fine.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9612030-2020-02415
MDR Report Key9717915
Report SourceCOMPANY REPRESENTATIVE,CONSUM
Date Received2020-02-17
Date of Report2020-02-17
Date of Event2020-02-12
Date Mfgr Received2020-02-12
Date Added to Maude2020-02-17
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 ContactJILL SARAIVA
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5086183640
Manufacturer G1COVIDIEN
Manufacturer StreetSRAGH INDUSTRIAL ESTATE
Manufacturer CityTULLAMORE, CO. OFFALY
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTROCAR CATH 24FR
Generic NameTROCAR
Product CodeDRC
Date Received2020-02-17
Model Number8888561050-
Catalog Number8888561050-
Lot Number18G250FHX
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer AddressSRAGH INDUSTRIAL ESTATE TULLAMORE, CO, OFFALY EI


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-17

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