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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 CDH33
Event Date 09/21/1998
Event Type  Malfunction   Patient Outcome  Other;
Event Description

It was reported that two cdh33's were used during a coloproctostomy, closure of end sigmoidostomy. It was reported by the affliate that the first instrument, the anvil shaft connected/locked with a trocar very difficult and the firing was not completed properly. A second cdh33 was used and, after firing in the stapler line, found the dehiscence (4/5 of the bowel diameter). The surgeon hand sutured the anastomosis. 10/02/1998 message from affiliate. The incomplete staple line occurred with both devices.

 
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Brand NamePROXIMATE I L S INTRALUMINAL STAPLER
Type of DeviceCIRCULAR STAPLERS
Baseline Brand NamePROXIMATE I L S CURVED INTRALUMINAL STAPLER
Baseline Generic NameCIRCULAR STAPLERS
Baseline Catalogue NumberCDH33
Baseline Model NumberCDH33
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 (Section G)
ETHICON ENDO-SURGERY, INC.
4545 creek rd.
cincinnati OH 45242 2839
Manufacturer Contact
gary leblanc
4545 creek rd
cincinnati , OH 45242
(513) 337 -8582
Device Event Key187684
MDR Report Key193157
Event Key181577
Report Number1527736-1998-03106
Device Sequence Number1
Product CodeGAG
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial,Followup
Report Date 09/24/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/23/1998
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date01/09/2003
Device Catalogue NumberCDH33
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Agena
Event Location Not Applicable
Date Manufacturer Received09/24/1998
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/01/1998
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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