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Adverse Event Report

ETHICON ENDO-SURGERY, S.A. DE C.V. LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER   back to search results
Catalog Number ER320
Event Date 08/11/1999
Event Type  Malfunction   Patient Outcome  Other;
Event Description

It was reported by the rep that the (2) er320 were used during a laparoscopic nissen fundoplication. It was reported that (2) instruments fired clip but the clip was not "closed". One sterile instrument from the same lot was also returned for replacement. There was no consequence to the pt.

 
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Brand NameLIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER
Type of DeviceCLIP APPLIER
Baseline Brand NameLIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER
Baseline Generic NameIMPLANTABLE CLIPS
Baseline Catalogue NumberER320
Baseline Model NumberER320
Baseline Device FamilyENDOSCOPIC SINGLE STAINLESS CLIPS
Baseline Device 510(K) NumberK830503
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? Yes
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed01/25/1994
Manufacturer (Section F)
ETHICON ENDO-SURGERY, S.A. DE C.V.
ave. delas torres #7125
col salvarcar 118
ciudad juarez, chih.
MEXICO
Manufacturer (Section D)
ETHICON ENDO-SURGERY, S.A. DE C.V.
ave. delas torres #7125
col salvarcar 118
ciudad juarez, chih.
MEXICO
Manufacturer (Section G)
ETHICON ENDO-SURGERY, INC.I/C
425 b panamerican drive
col. salvarcar 118, ciudad jua
el paso TX 79907
Manufacturer Contact
john gagliardi
4545 creek road
cincinnati , OH 45242
(513) 483 -8969
Device Event Key231103
MDR Report Key238503
Event Key223755
Report Number1527736-1999-04628
Device Sequence Number1
Product CodeGDO
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial,Followup
Report Date 08/11/1999
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/31/1999
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date11/03/2003
Device Catalogue NumberER320
Device LOT NumberL4CW43
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 Received08/11/1999
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/01/1998
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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