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Adverse Event Report

ETHICON ENDO-SURGERY, INC. S.A. DE C.V. ENDOPATH TROCAR SLEEVE TROCAR SLEEVES   back to search results
Catalog Number 511SL
Event Date 10/14/1998
Event Type  Malfunction   Patient Outcome  Other;
Event Description

It was reported that a 511sl was used during a laparoscopic cholecystectomy. It was reported by the rep that the seal on 511sl split. Case finished by replacing trocar. There was no consequence to the pt.

 
Manufacturer Narrative

Sent 11/5/98. A1,2,3,4; b6,7; d10: info not provided during initial contact. F/u letter sent to facility requesting add'l info. D5,6; h4,6; e2,3: info is unavailable, not provided by the user facility. The analysis results found that the sleeve was returned with the outer gasket torn, and no pieces were missing. While no conclusion could be reached as to how the gasket became torn, the appropriate engineering personnel have been notified and co documented the reported circumstances and analysis results.

 
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Brand NameENDOPATH TROCAR SLEEVE
Type of DeviceTROCAR SLEEVES
Baseline Brand NameENDOPATH TROCAR SLEEVE
Baseline Generic NameTROCAR ACCESSORIES
Baseline Catalogue Number511SL
Baseline Model Number511SL
Baseline Device FamilyTROCAR ACCESSORIES
Baseline Device 510(K) NumberK924035
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed07/14/1996
Manufacturer (Section F)
ETHICON ENDO-SURGERY, INC. S.A. DE C.V.
ave de las torres #7125
col salvarcar 118
juarez
MEXICO
Manufacturer (Section D)
ETHICON ENDO-SURGERY, INC. S.A. DE C.V.
ave de las torres #7125
col salvarcar 118
juarez
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 Key190406
MDR Report Key195977
Event Key184168
Report Number1527736-1998-03411
Device Sequence Number1
Product CodeGCJ
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Nurse
Remedial Action Other
Type of Report Initial
Report Date 10/16/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/05/1998
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number511SL
Device LOT NumberL4AW5V
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Agena
Event Location Not Applicable
Date Manufacturer Received10/16/1998
Was Device Evaluated By Manufacturer? Yes
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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