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Adverse Event Report

EES-JUAREZ ENDOPATH DILATING TIP TROCAR   back to search results
Catalog Number 511SD
Event Type  Injury   Patient Outcome  Other; Required Intervention
Event Description

During a diagnostic laparoscopy the 511sd safety shield did not engage and nicked the vena cava. The patient had to be opened and examined. No blood loss was noticed. The patient is fine. Clinical follow-up: 2/18/97 1144 message and 800# left on risk manager's pm. 2/18/97 1600 risk management called and will call back if able to gather further information. She was not aware of the event. Tkb 2/21/97 - risk management said the surgeon reported the patient is doing well at this time. To contact the surgeon for further information.

 
Manufacturer Narrative

A1,2,3,4; b3,6,7; d10: contacted facility, information not provided. D5,6; h4: information not available, device not returned for analysis.

 
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Brand NameENDOPATH DILATING TIP TROCAR
Type of DeviceTROCAR
Baseline Brand NameENDOPATH DILATING TIP TROCAR
Baseline Generic NameTROCARS
Baseline Catalogue Number511SD
Baseline Model Number511SD
Baseline Device FamilyTROCARS
Baseline Device 510(K) NumberK893715
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed02/08/1994
Manufacturer (Section F)
EES-JUAREZ
m sandovai e. ave. rio bravo
d.b. cludad, juarez
chihuahua
MEXICO
Manufacturer (Section D)
EES-JUAREZ
m sandovai e. ave. rio bravo
d.b. cludad, juarez
chihuahua
MEXICO
Manufacturer (Section G)
ETHICON ENDO-SURGERY, INC.
4545 creek rd.
cincinnati OH 45242 2839
Manufacturer Contact
kay jackson
4545 creek rd
cincinnati , OH 45242-2839
(513) 483 -8148
Device Event Key81294
MDR Report Key81885
Event Key77048
Report Number1527736-1997-00265
Device Sequence Number1
Product CodeGCJ
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 03/13/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/14/1997
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number511SD
OTHER Device ID NumberBATCH #UNK
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Agena
Event Location Not Applicable
Date Manufacturer Received02/12/1997
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Database last updated on January 30, 2009

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