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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 Type  Malfunction   Patient Outcome  Other;
Event Description

It was reported that the handpiece activates intermittently. The customer states that the case was completed with no patient consequence with the use of a second handpiece.

 
Manufacturer Narrative

Based on analysis results, this complaint is now determined to be a mdr malfunction. Evaluation summary: the hand piece was unable to be repaired. The hand piece was returned with gouges on the mount face and moisture ingress. No longer meets specification for frequency, phase margin and impedance.

 
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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 Key381450
MDR Report Key392424
Event Key370697
Report Number1527736-2002-00885
Device Sequence Number1
Product CodeLFL
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 04/09/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/02/2002
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date09/09/2006
Device Catalogue NumberHP052
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 Received04/09/2002
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/01/2001
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 February 28, 2009

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