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Adverse Event Report

ETHICON ENDO-SURGERY, INC. S.A. DE C.V. LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER CLIP APPLIERS-ENDOSCOPIC   back to search results
Catalog Number ER320
Event Date 05/01/1999
Event Type  Malfunction   Patient Outcome  Other;
Event Description

It was reported that the device was used during a laparoscopic cholecystectomy. It was reported by the rep that after placing clips on the cystic duct, the surgeon noticed that the clips were not secure and eventually fell off instrument. Another er320 was opened and used to complete the case. There was no consequence to the pt.

 
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Brand NameLIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER
Type of DeviceCLIP APPLIERS-ENDOSCOPIC
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, INC. S.A. DE C.V.
ave delas torres #7125
col salvarcar 118
ciudad juarez, chih.
MEXICO
Manufacturer (Section D)
ETHICON ENDO-SURGERY, INC. S.A. DE C.V.
ave delas torres #7125
col salvarcar 118
ciudad juarez, chih.
MEXICO
Manufacturer (Section G)
ETHICON ENDO-SURGERY, INC.
ave delas torres 7125
col. salvarcar 118
ciudad juarez, chih.
MEXICO
Manufacturer Contact
john gagliardi manager
4545 creek rd
cincinnati , OH 45242
(513) 483 -8969
Device Event Key219148
MDR Report Key225981
Event Key212103
Report Number1527736-1999-03167
Device Sequence Number1
Product CodeGDO
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Nurse
Remedial Action Other
Type of Report Initial,Followup
Report Date 05/13/1999
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/27/1999
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date12/05/2003
Device Catalogue NumberER320
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 Received05/13/1999
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/01/1999
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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