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Adverse Event Report

ETHICON ENDO-SURGERY, INC.(TORRES) ENDOPATH ENDOPATH DILATING TIP TROCAR ENDOPATH DILATING TIP TROCARS   back to search results
Catalog Number 355LD
Event Date 07/01/2002
Event Type  Malfunction   Patient Outcome  Other;
Manufacturer Narrative

Eval summary: the analysis results confirmed that the 355ld instrument was nonfunctional. It was tested for functionality and would not arm due to a misassembled reset button spring. The batch history records were reviewed with no anomalies noted during the mfg process.

 
Event Description

It was reported that the device was used during an unk procedure. The device remained armed during insertion. There was no pt consequence.

 
Manufacturer Narrative

No further info is available regarding the reported event. D5,6;h4,6: info anticipated, but unavailable at this time.

 
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Brand NameENDOPATH ENDOPATH DILATING TIP TROCAR
Type of DeviceENDOPATH DILATING TIP TROCARS
Baseline Brand NameDILATING TIP TROCAR
Baseline Generic NameTROCARS
Baseline Catalogue Number355LD
Baseline Device FamilyTROCARS
Baseline Device 510(K) NumberK893715
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed08/03/1989
Manufacturer (Section F)
ETHICON ENDO-SURGERY, INC.(TORRES)
avenida de las torres 7125
parque indust salvarcar 118
ciudad juarez chihuahua
MEXICO
Manufacturer (Section D)
ETHICON ENDO-SURGERY, INC.(TORRES)
avenida de las torres 7125
parque indust salvarcar 118
ciudad juarez chihuahua
MEXICO
Manufacturer Contact
tom bosticco manager
4545 creek road
cincinnati , OH 45242
(513) 337 -8935
Device Event Key401933
MDR Report Key412882
Event Key390415
Report Number1527736-2002-01764
Device Sequence Number1
Product CodeGCJ
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Nurse
Remedial Action Other
Type of Report Initial,Followup
Report Date 07/22/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/22/2002
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date03/22/2007
Device Catalogue Number355LD
Device LOT NumberR4T116
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Not Applicable
Date Manufacturer Received07/22/2002
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/01/2002
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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