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Adverse Event Report

ETHICON ENDO-SURGERY-ALB PROXIMATE I L S INTRALUMINAL STAPLER CIRCULAR STAPLERS   back to search results
Catalog Number CDH29
Event Date 07/24/2000
Event Type  Malfunction   Patient Outcome  Other;
Event Description

It was reported that (1) device was used during an ileostomy procedure. It was reported by the affiliate that the surgeon was planning to perform the ileostomy and decided to try creating a low anterior resection. When he connected the anvil to the trocar and tried to turn the knob to fire, the anvil popped off. The second time the instrument worked fine. The donut was examined and tested and seemed to be ok. However, it was found that there was a hole in the anastomosis and because of this, the surgeon reverted to original plan of a permanent ileostomy. The device was discarded.

 
Manufacturer Narrative

Sent 08/03/2000. A1,2,3,4; b6,7; d10: info not provided by affiliate. D5,6; h4: info not available, device not returned for analysis.

 
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Brand NamePROXIMATE I L S INTRALUMINAL STAPLER
Type of DeviceCIRCULAR 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 univ blvd., se
albuquerque NM 87125 6202
Manufacturer (Section D)
ETHICON ENDO-SURGERY-ALB
3801 univ blvd., se
albuquerque NM 87125 6202
Manufacturer Contact
john huff, manager
4545 creek road
cincinnati , OH 45242
(513) 337 -7460
Device Event Key279263
MDR Report Key288571
Event Key270788
Report Number1527736-2000-03517
Device Sequence Number1
Product CodeGAG
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial
Report Date 07/28/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/03/2000
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCDH29
Device LOT NumberN4HR3W
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 Received07/28/2000
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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