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Adverse Event Report

ETHICON ENDO-SURGERY, INC. (JUAREZ) ENDOPATH ENDOPATH ETS FLEX 45MM LINEAR CUTTERS - ETS45MM   back to search results
Catalog Number ATW45
Event Date 03/05/2002
Event Type  Malfunction   Patient Outcome  Other;
Event Description

It was reported that during a laparoscopic gastric bypass the staple lines opened up. The surgeon had to hand sew the staple lines. There was no consequence to the patient. The devices were discarded.

 
Manufacturer Narrative

D5,6; h4: information not available, device not returned for analysis.

 
Manufacturer Narrative

The complaint could not be confirmed due to the limited amount of info provided. Due to this fact and the severity of the event, no further investigation is being conducted at this time. Complaint info is trended on a regular basis to determine if further investigation is warranted. D5, 6; h4: device was not returned and lot or batch identification was not provided.

 
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Brand NameENDOPATH ENDOPATH ETS FLEX 45MM
Type of DeviceLINEAR CUTTERS - ETS45MM
Baseline Brand NameARTICULATING LINEAR CUTTER
Baseline Generic NameLINEAR CUTTER
Baseline Catalogue NumberATW45
Baseline Device FamilyLINEAR CUTTERS - CONVENTIONAL
Baseline Device 510(K) NumberK843034
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed09/17/1984
Manufacturer (Section F)
ETHICON ENDO-SURGERY, INC. (JUAREZ)
avenida de las torres 7125
parque indust. salvarcar 118
ciudad juarez chihuahua
MEXICO
Manufacturer (Section D)
ETHICON ENDO-SURGERY, INC. (JUAREZ)
avenida de las torres 7125
parque indust. salvarcar 118
ciudad juarez chihuahua
MEXICO
Manufacturer Contact
tom bosticco manager
4545 creek road
cincinnati , OH 45242
(513) 337 -8935
Device Event Key375553
MDR Report Key386515
Event Key364967
Report Number1527736-2002-00664
Device Sequence Number1
Product CodeGCJ
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial,Followup
Report Date 03/07/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/03/2002
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberATW45
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Agena
Event Location Not Applicable
Date Manufacturer Received03/07/2002
Was Device Evaluated By Manufacturer? No
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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