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Adverse Event Report

ETHICON ENDO-SURGERY - ALB PROXIMATE PROXIMATE I L S CURVED INTRALUMINAL STAPLE PROXIMATE ILS CIRCULAR STAPLERS   back to search results
Catalog Number CDH29
Event Type  Malfunction   Patient Outcome  Other;
Manufacturer Narrative

The instrument was received in good condition. There were no staples present and the breakaway washer was cut, indicating that the instrument had achieved a full firing stroke. The instrument was reloaded with staples and fired. It fired and formed all the staples as well as completely cut the test medica and the breakaway washer without incident. There were no anomalies noted with the functionality of the device or with the firign of the staples. The batch history records were reviewed with no anomalies noted. The device was found to be conforming with respect to manufacturing requirements.

 
Event Description

The device was used during a colorectal anastomosis. The device cut the tissue, but did not staple. Case was completed with hand suture. There were no patient consequences.

 
Manufacturer Narrative

H4,6: info anticipated, but unavailable at this time.

 
Search Alerts/Recalls

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Brand NamePROXIMATE PROXIMATE I L S CURVED INTRALUMINAL STAPLE
Type of DevicePROXIMATE ILS CIRCULAR STAPLERS
Baseline Brand NamePROXIMATE ILS INTRALUMINAL CIRCULAR STAPLER
Baseline Generic NameCIRCULAR STAPLERS
Baseline Catalogue NumberCDH29
Baseline Device FamilyPROXIMATE ILS CIRCULAR STAPLERS
Baseline Device 510(K) NumberK940967
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed06/20/1980
Manufacturer (Section F)
ETHICON ENDO-SURGERY - ALB
3801 university blvd., se
albuquerque NM 87125 6202
Manufacturer (Section D)
ETHICON ENDO-SURGERY - ALB
3801 university blvd., se
albuquerque NM 87125 6202
Manufacturer Contact
tom bosticco manager
4545 creek road
cincinnati , OH 45242
(513) 337 -8935
Device Event Key410454
MDR Report Key421423
Event Key398563
Report Number1527736-2002-02051
Device Sequence Number1
Product CodeGAG
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Remedial Action Other
Type of Report Initial,Followup
Report Date 09/11/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/08/2002
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date01/01/2007
Device Catalogue NumberCDH29
Device LOT NumberR4R80D
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 Received09/11/2002
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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