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Adverse Event Report

ETHICON ENDO-SURGERY-ALB PROXIMATE ILS INTRALUMINAL STAPLER CIRCULAR STAPLERS   back to search results
Catalog Number CDH25
Event Type  Malfunction   Patient Outcome  Other;
Manufacturer Narrative

Analysis conclusion: the instrument was rec'd in good condition. The instrument was returned with the breakaway washer present and cut, indicating that the instrument had been fired through a full firing stroke. The instrument was reloaded with staples and a breakaway washer and fired. It fired and formed all the staples as well as completely cut the test media and the breakaway washer. The batch history records were reviewed with no anomalies noted during mfg. It could not be determined what may have caused the reported incident. The appropriate personnel have been notified of the reported incident.

 
Event Description

It was reported by the affiliate that the (1) cdh25 was used during an unknown procedure. It was reported that the surgeon was going to staple the esophagus and the instrument did not staple the tissue. The device was also difficult to remove. There was no pt consequence.

 
Manufacturer Narrative

Sent: 06/27/2000. A1,2,3,4; b3,6,7; d10; e1: info not provided by affiliate. D5; h4,6: info anticipated, but unavailable at this time.

 
Search Alerts/Recalls

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Brand NamePROXIMATE ILS INTRALUMINAL STAPLER
Type of DeviceCIRCULAR STAPLERS
Baseline Brand NamePROXIMATE I L S CURVED INTRALUMINAL STAPLER
Baseline Generic NameCIRCULAR STAPLERS
Baseline Catalogue NumberCDH25
Baseline Model NumberCDH25
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.
avenida de las torres 7125
parque industrial salv. 118
ciudad juarez chihuahua
MEXICO
Manufacturer Contact
john huff manager
4545 creek road
cincinnati , OH 45242
(513) 337 -7460
Device Event Key274793
MDR Report Key283962
Event Key266375
Report Number1527736-2000-02802
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 05/26/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/27/2000
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date03/13/2003
Device Catalogue NumberCDH25
Device LOT NumberL49U18
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 Received05/26/2000
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/01/1998
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 February 28, 2009

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