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Adverse Event Report

EES-SMITHFIELD HARMONIC SCALPEL LAPAROSONIC COAGULATING SHEARS   back to search results
Catalog Number LCS15
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

During a laparoscopic nissen fundoplication the lcs15 appeared to work only intermittently. There was a loud and strange squealing noise from the hand piece. The surgeon could not get the instrument to work properly even after changing to a new lcs. The procedure was then converted to open and the case was completed. The rep went to the hosp checked the device and it seems to be working correctly. Clinical follow up: 3/18/97 message and 800# left for risk mgr. 3/18/97 a lady from utilization review called and stated she would forward the message on to risk mgmt. 2/24/97 dr was performing a laparoscopic procedures and was using the lcs15. During the procedure the instrument failed to work. Due to anatomic factors and less related to the instrument, he converted to an open procedure. Pt is doing satisfactory.

 
Manufacturer Narrative

A1,2,3,4; b6,7; d10: contacted facility, info not provided. H6: code 100 & 400 (other): blade cracked at tip.

 
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Brand NameHARMONIC SCALPEL LAPAROSONIC COAGULATING SHEARS
Type of DeviceCOAGULATING SHEAR
Baseline Brand NameHARMONIS SCALPEL LAPAROSONIC COAGULATING SHEARS
Baseline Generic NameELECTRO-SURGERY ACCESSORIES
Baseline Catalogue NumberLCS15
Baseline Model NumberLCS15
Baseline Device FamilyELECTRO-SURGERY ACCESSORIES - ENDOS
Baseline Device 510(K) NumberK904993
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed01/25/1991
Manufacturer (Section F)
EES-SMITHFIELD
25 thurber blvd
smithfield RI 02917
Manufacturer (Section D)
EES-SMITHFIELD
25 thurber blvd
smithfield RI 02917
Manufacturer (Section G)
ETHICON ENDO-SURGERY, INC.
4545 creek rd.
cincinnati OH 45242 2839
Manufacturer Contact
tom bosticco
4545 creek rd
cincinnati , OH 45242
(513) 337 -8935
Device Event Key77900
MDR Report Key78271
Event Key73687
Report Number1527736-1997-00290
Device Sequence Number1
Product CodeKNS
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Nurse
Remedial Action Other
Type of Report Initial
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/20/1997
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberLCS15
Device LOT NumberLE0830-3
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Agena
Event Location Not Applicable
Date Manufacturer Received02/14/1997
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/01/1996
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 January 30, 2009

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