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Adverse Event Report

ETHICON ENDO-SURGERY, INC. (TORRES) PROXIMATE LINEAR CUTTER RELOAD LINEAR CUTTERS - CONVENTIONAL   back to search results
Catalog Number TCR75
Event Date 06/17/2002
Event Type  Injury   Patient Outcome  Required Intervention;
Manufacturer Narrative

The complaint could not be confirmed due to the limited amount of information provided. Complaint information is trended on a regular basis to determine if further investigation. Is warranted.

 
Event Description

It was reported that the device was used during an ileocolostomy. The surgeon used the device and four reloads. The surgeon states that ten days postoperatively the pt required additional surgery because the second firing failed. The second surgery was completed. The consequence to the pt is unknown.

 
Manufacturer Narrative

D5,6; h4: info not available, device not returned for analysis.

 
Search Alerts/Recalls

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Brand NamePROXIMATE LINEAR CUTTER RELOAD
Type of DeviceLINEAR CUTTERS - CONVENTIONAL
Baseline Brand NameLINEAR CUTTER RELOADING UNIT WITH SAFETY LOCKOUT
Baseline Generic NameLINEAR CUTTER
Baseline Catalogue NumberTCR75
Baseline Device FamilyLINEAR CUTTERS - CONVENTIONAL
Baseline Device 510(K) NumberK843034
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed09/17/1984
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 Key393882
MDR Report Key404885
Event Key382673
Report Number1527736-2002-01466
Device Sequence Number1
Product CodeGCJ
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Remedial Action Other
Type of Report Initial,Followup
Report Date 06/27/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/15/2002
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberTCR75
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Not Applicable
Date Manufacturer Received06/27/2002
Was Device Evaluated By Manufacturer? No
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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