BLUNTPORT PLUS 179775P

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-27 for BLUNTPORT PLUS 179775P manufactured by Covidien Lp Llc North Haven.

Event Text Entries

[87730681]
Patient Sequence No: 1, Text Type: N, H10


[87730682] According to the reporter, prior to the laparoscopic cholecystectomy operation, the customer tried to insert obturator into cannula, but could not. Another obturator was opened and it worked fine. The procedure was completed with another device. No injury.
Patient Sequence No: 1, Text Type: D, B5


[112626924] Evaluation summary: post market vigilance (pmv) led an evaluation of one device. The visual inspection of the returned product noted; the port seal was received without the cannula and the insufflation port was disengaged. The condition of the device precludes functional testing. Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture. Analysis concluded there were no assembly component related failures; therefore, a device history record will not be performed. Replication of the disengaged valve may occur when mishandled during clinical application. The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident. Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1219930-2017-07448
MDR Report Key6897681
Date Received2017-09-27
Date of Report2017-11-17
Date of Event2017-09-01
Date Mfgr Received2017-10-27
Date Added to Maude2017-09-27
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 ContactSHARON MURPHY
Manufacturer Street60 MIDDLETOWN AVE
Manufacturer CityNORTH HAVEN CT 06473
Manufacturer CountryUS
Manufacturer Postal06473
Manufacturer Phone2034925267
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 NameBLUNTPORT PLUS
Generic NameGOUGE, SURGICAL, GENERAL & PLASTIC SURGERY
Product CodeGDH
Date Received2017-09-27
Returned To Mfg2017-09-26
Model Number179775P
Catalog Number179775P
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
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 2017-09-27

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