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Adverse Event Report

ETHICON ENDO SURGERY ENDOPATH ETS FLEX LINEAR CUTTER   back to search results
Catalog Number ATW35
Event Date 08/21/1998
Event Type  Malfunction   Patient Outcome  Other;
Event Description

It was reported by the rep the device was used during a laparoscopic assisted vaginal hysterectomy. It was reported after firing the atw35 multiple times, there was oozing of blood at the proximal tip of staple line. Some of the staples appeared to be partially formed. An er320 was used to stop the oozing. The device was not saved. After placing the endo-clips the case was completed without incident. There was no consequence to the pt.

 
Manufacturer Narrative

A1,2,4;b6,7;d10: info not provided during initial contact. Follow up letter sent to facility, requesting add'l info. D5,6;h4: info not available, device not returned for analysis.

 
Search Alerts/Recalls

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Brand NameENDOPATH ETS FLEX
Type of DeviceLINEAR CUTTER
Baseline Brand NameETS FLEX
Baseline Generic NameLINEAR CUTTER
Baseline Catalogue NumberATW35
Baseline Device FamilyLINEAR CUTTERS - ENDOSCOPIC
Baseline Device 510(K) NumberK915099
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed09/19/1992
Manufacturer (Section F)
ETHICON ENDO SURGERY
4545 creek rd.
cincinnati OH 45242
Manufacturer (Section D)
ETHICON ENDO SURGERY
4545 creek rd.
cincinnati OH 45242
Manufacturer (Section G)
ETHICON ENDO-SURGERY, INC.
4545 creek rd.
cincinnati OH 45242 2839
Manufacturer Contact
tom bosticco
4545 creek road
cincinnati , OH 45242
(513) 337 -8935
Device Event Key183371
MDR Report Key188685
Event Key177373
Report Number1527736-1998-02775
Device Sequence Number1
Product CodeKOG
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 08/26/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/23/1998
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberATW35
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 Received08/26/1998
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 February 28, 2009

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