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Adverse Event Report

ETHICON ENDO-SURGERY - ALB HARMONIC SCALPEL ULTRACISION HAND PIECE ULTRASONIC-SURGERY DEVICES - REUSAB   back to search results
Catalog Number HP052
Event Date 11/28/2001
Event Type  Malfunction   Patient Outcome  Other;
Event Description

It was reported that the device was to be used during a general surgical procedure. It was reported that the device "will not work". A second device was used to complete the procedure. There was no consequence to the pt.

 
Manufacturer Narrative

Evaluation summary: the hand piece was unable to be repaired. The hand piece was returned in good physical condition. Results - no longer meets the specification for frequency and phase margin.

 
Search Alerts/Recalls

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Brand NameHARMONIC SCALPEL ULTRACISION HAND PIECE
Type of DeviceULTRASONIC-SURGERY DEVICES - REUSAB
Baseline Brand NameULTRACISION HAND PIECE
Baseline Generic NameGENERATOR
Baseline Catalogue NumberHP052
Baseline Device FamilyULTRASONIC-SURGERY DEVICES - REUSAB
Baseline Device 510(K) NumberK905315
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed02/15/1991
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 Contact
tom bosticco manager
4545 creek road
cincinnati , OH 45242
(513) 337 -8935
Device Event Key376145
MDR Report Key387118
Event Key365549
Report Number1527736-2002-00656
Device Sequence Number1
Product CodeLFL
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 03/27/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/03/2002
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date01/05/2006
Device Catalogue NumberHP052
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Not Applicable
Date Manufacturer Received03/27/2002
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/01/2001
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 06, 2009

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