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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 06/26/1998
Event Type  Malfunction   Patient Outcome  Other;
Event Description

It was reported by the rep the device was used during laparoscopic anterior resection. It was reported the scrub nurse went to prepare the stapler but retracting the trocar, the knob came off. Another cdh was pulled to complete the case not determent to the pt. There was no consequence to the pt.

 
Manufacturer Narrative

Tracking # 59891. A1,2,3,4; b6,7; d10: info not provided during initial contact. Follow up letter sent to facility requesting additional info.

 
Search Alerts/Recalls

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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 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 Key174564
MDR Report Key179528
Event Key168753
Report Number1527736-1998-02239
Device Sequence Number1
Product CodeGAG
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 06/29/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/27/1998
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date03/02/2003
Device Catalogue NumberCDH29
Device LOT NumberL49R0F
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Device Agena
Event Location Not Applicable
Date Manufacturer Received06/29/1998
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 January 06, 2009

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