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Adverse Event Report

ETHICON ENDO-SURGERY, INC. (CINCINNATI) LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER ENDOSCOPIC MULTIPLE CLIP APPLIER   back to search results
Catalog Number ER320
Event Date 03/01/2004
Event Type  Malfunction   Patient Outcome  Other;
Event Description

It was reported that during a lap cholecystectomy procedure, during the procedure it was described that the clips were not forming properly around the vessel. Several had to be removed and replaced to get adequate sealing of the vessel. Some scissoring of the clips were also noted. No pt consequence. One device returning.

 
Manufacturer Narrative

D5, 6; h4, 6: info anticipated, but unavailable at this time.

 
Search Alerts/Recalls

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Brand NameLIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER
Type of DeviceENDOSCOPIC MULTIPLE CLIP APPLIER
Baseline Brand NameLIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER
Baseline Generic NameENDOSCOPIC CLIP APPLIER
Baseline Catalogue NumberER320
Other Baseline ID NumberBATCH #:J44J8R
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
ETHICON ENDO-SURGERY, INC. (CINCINNATI)
4545 creek rd.
cincinnati OH 45242 2803
Manufacturer (Section D)
ETHICON ENDO-SURGERY, INC. (CINCINNATI)
4545 creek rd.
cincinnati OH 45242 2803
Manufacturer (Section G)
ETHICON ENDO SURGERY, INC. (INDEPENDENCIA)
blvd independencia #1151
juarez chihuahua
MEXICO
Manufacturer Contact
gary leblanc
4545 creek rd
cincinnati , OH 45242-2803
(513) 337 -8582
Device Event Key527999
MDR Report Key538728
Event Key511483
Report Number1527736-2004-00818
Device Sequence Number1
Product CodeGDO
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Nurse
Remedial Action Other
Type of Report Initial
Report Date 03/01/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/25/2004
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberER320
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Ageunknown
Event Location Not Applicable
Date Manufacturer Received03/01/2004
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
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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