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Adverse Event Report

ETHICON ENDO-SURGERY, INC., EES-ALBUQUERQUE LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER ENDOSCOPIC CLIP APPLIER   back to search results
Catalog Number ER320
Event Date 05/19/1997
Event Type  Malfunction   Patient Outcome  Other;
Manufacturer Narrative

Trackibng #. 21160. D5,6; h4: info not available, device not returned for analysis.

 
Event Description

It was reported during a laparoscopic cholecystectomy the surgeon saw something white/clear in the pt. The surgeon stated it looked like the plastic diaphragm from the first seal. Before the piece could be removed, it disappeared. The piece was confirmed by x-ray. The surgeon did not open the pt to remove the piece. The pt was informed. The fdc 16 kit was used and the complete kit will be returned. All the instruments appear to be intact.

 
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Brand NameLIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER
Type of DeviceENDOSCOPIC CLIP 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, INC., EES-ALBUQUERQUE
3801 university blvd., se
albuquerque NM 87125 6202
Manufacturer (Section D)
ETHICON ENDO-SURGERY, INC., EES-ALBUQUERQUE
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 Key97675
MDR Report Key99111
Event Key93206
Report Number1527736-1997-01320
Device Sequence Number1
Product CodeGDO
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 06/16/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/17/1997
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? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Agena
Event Location Not Applicable
Date Manufacturer Received05/19/1997
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 February 28, 2009

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