SURGINEEDLE 172015

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-20 for SURGINEEDLE 172015 manufactured by Covidien Lp Llc North Haven.

Event Text Entries

[112163374] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[112163375] According to the reporter, during a laparoscopic cholecystectomy, the valve of the device dislodged and fell inside the patient? S cavity. It was located and removed and the case was completed. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1219930-2018-03239
MDR Report Key7620528
Date Received2018-06-20
Date of Report2018-06-20
Date of Event2018-05-24
Date Mfgr Received2018-06-05
Date Added to Maude2018-06-20
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 ContactLISA HERNANDEZ
Manufacturer Street60 MIDDLETOWN AVE
Manufacturer CityNORTH HAVEN CT 06473
Manufacturer CountryUS
Manufacturer Postal06473
Manufacturer Phone2034925563
Manufacturer G1COVIDIEN LP LLC NORTH HAVEN
Manufacturer Street195 MCDERMOTT RD
Manufacturer CityNORTH HAVEN CT 06473
Manufacturer CountryUS
Manufacturer Postal Code06473
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameSURGINEEDLE
Generic NamePNEUMOPERITONEUM NEEDLE
Product CodeFHO
Date Received2018-06-20
Model Number172015
Catalog Number172015
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN LP LLC NORTH HAVEN
Manufacturer Address195 MCDERMOTT RD NORTH HAVEN CT 06473 US 06473


Patients

Patient NumberTreatmentOutcomeDate
10 2018-06-20

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