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Adverse Event Report

ETHICON ENDO-SURGERY HARMONIC SCALPEL CURVED SHEARS ULTRASONIC ACCESSORY   back to search results
Catalog Number CS23C
Event Date 10/22/2002
Event Type  Injury   Patient Outcome  Other; Required Intervention
Event Description

It was reported that during a lap nissen, the shears was not coagulating effectively at minimum power when used on the short gastric vessels. It also did not cause normal blanching of tissue during use or when tested by touching the spleen. When the device was used on the splenetic vessel, it compressed the vessel, then burst it. The case was converted to open to suture the burst vessel and the gastric vessels, which were now bleeding slightly. The pt was in stable condition the following day when the event was reported to the company sales rep. Risk management has the shears.

 
Manufacturer Narrative

D5, 6; h4, 6: info not available but anticipated.

 
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Brand NameHARMONIC SCALPEL CURVED SHEARS
Type of DeviceULTRASONIC ACCESSORY
Baseline Brand NameULTRACISION COAGULATING SHEARS - CURVED
Baseline Generic NameULTRASONIC ACCESSORIES
Baseline Catalogue NumberCS23C
Baseline Device FamilyULTRACISION SURGICAL DEVICES, SHEARS, ENDOSCOPIC
Baseline Device 510(K) NumberK925699
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed05/17/1993
Manufacturer (Section F)
ETHICON ENDO-SURGERY
4545 creek rd.
cincinnati OH 45242 2839
Manufacturer (Section D)
ETHICON ENDO-SURGERY
4545 creek rd.
cincinnati OH 45242 2839
Manufacturer Contact
tom bosticco
4545 creek road
cincinnati , OH 45242
(513) 337 -8935
Device Event Key418409
MDR Report Key429403
Event Key406221
Report Number1527736-2002-02540
Device Sequence Number1
Product CodeLFL
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial
Report Date 10/23/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/19/2002
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberCS23C
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 Received10/23/2002
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

Patient TREATMENT DATA
Date Received: 11/19/2002 Patient Sequence Number: 1
#TreatmentTreatment Date
1,GENERATOR, HANDPIECE.,

Database last updated on January 30, 2009

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