INSUFFLATION & ACCESS NEEDLE, 14G RS100000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2001-07-09 for INSUFFLATION & ACCESS NEEDLE, 14G RS100000 manufactured by United States Surgical Corporation.

Event Text Entries

[20681639] Reportedly, the tip of the insufflation needle broke off and fell into the patient's cavity. The tip was laparoscopically retrieved. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2647580-2001-00376
MDR Report Key342080
Report Source05,06,07
Date Received2001-07-09
Date of Report2001-06-14
Date of Event2001-05-29
Date Facility Aware2001-05-29
Date Mfgr Received2001-06-14
Device Manufacturer Date2001-03-01
Date Added to Maude2001-07-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactLAURA POEPE, RN, MA, CEN
Manufacturer Street195 MCDERMOT ROAD
Manufacturer CityNORTH HAVEN CT 06473
Manufacturer CountryUS
Manufacturer Postal06473
Manufacturer Phone2034926334
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINSUFFLATION & ACCESS NEEDLE, 14G
Generic Name*
Product CodeFHO
Date Received2001-07-09
Returned To Mfg2001-06-19
Model NumberNA
Catalog NumberRS100000
Lot NumberP1C621
ID NumberNA
Device Expiration Date2006-04-01
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Age2 MO
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key331414
ManufacturerUNITED STATES SURGICAL CORPORATION
Manufacturer AddressSABANETAS INDUSTRIAL PARK MERCEDITA PR 00715 US
Baseline Brand NameSTEP REPOSABLE INSUFFLATION & ACCESS NEEDLE, 14G
Baseline Generic NameSURGICAL ACCESS DEVICE
Baseline Model NoNA
Baseline Catalog NoRS100000
Baseline IDNA


Patients

Patient NumberTreatmentOutcomeDate
10 2001-07-09

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