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Adverse Event Report

ETHICON ENDO-SURGERY - ALB LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER   back to search results
Catalog Number ER220
Event Date 07/21/1998
Event Type  Malfunction   Patient Outcome  Other;
Event Description

It was reported by the rep the device was used during a laparoscopic toupet. It was reported the surgeon attempted to place a medium clip from the er220 erca and experienced a malfunction in the formation of the clip onto suture. A second clip applier was used to successfully place clips to secure sutures placed. 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 NumberER220
Baseline Model NumberER220
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 - 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
tom bosticco
4545 creek rd
cincinnati , OH 45242-2839
(513) 337 -8935
Device Event Key175599
MDR Report Key180570
Event Key169761
Report Number1527736-1998-02350
Device Sequence Number1
Product CodeGDO
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Remedial Action Other
Type of Report Initial,Followup
Report Date 07/21/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/03/1998
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date02/18/2002
Device Catalogue NumberER220
Device LOT NumberK4B025
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 Received07/21/1998
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/01/1997
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 December 31, 2008

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