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Adverse Event Report

ETHICON ENDOSURGERY INC ENDOPATH ETS   back to search results
Catalog Number TSW35
Event Date 05/08/1997
Event Type  Injury  
Manufacturer Narrative

B6; d10: info not provided during initial contact. Follow up letter sent to facility requesting add'l info. D5,6; h4: info unavailable , device not returned for analysis.

 
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Brand NameENDOPATH ETS
Baseline Brand NameETS
Baseline Generic NameLINEAR CUTTER
Baseline Catalogue NumberTSW35
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 ENDOSURGERY INC
4545 creek rd
cincinnati OH 45242
Manufacturer (Section D)
ETHICON ENDOSURGERY INC
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 Key100199
MDR Report Key101812
Event Key95703
Report Number1527736-1997-01443
Device Sequence Number1
Product CodeKOG
Report Source Manufacturer
Source Type Company Representative
Remedial Action Other
Type of Report Initial
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/30/1997
Is This An Adverse Event Report? No
Device Operator Invalid Data
Device Catalogue NumberTSW35
Was Device Available For Evaluation? No Answer Provided
Was the Report Sent to FDA? No
Date Manufacturer Received06/02/1997
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 February 28, 2009

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