FDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH U.S. Food and Drug Administration Center for Devices and Radiological Health [Skip navigation]
horizonal rule
Super Search
510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA
CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards
 

 

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 03/11/2002
Event Type  Malfunction   Patient Outcome  Other;
Manufacturer Narrative

Based on analysis results, this complaint is now determined to be an mdr malfunction. Evaluation summary: the hand piece was unable to be repaired. The hand piece was returned with moisture ingress, a cracked disk and had a solid tone during testing. No longer meets specification for frequency, phase margin and impedance.

 
Event Description

It was reported that the device gave solid tones while in use. The case was finished the same device with no consequences to the patient.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

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 bostico manager
4545 creek road
cincinnati , OH 45242
(513) 337 -8935
Device Event Key380638
MDR Report Key391598
Event Key369881
Report Number1527736-2002-00866
Device Sequence Number1
Product CodeLFL
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 04/03/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/30/2002
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date10/16/2006
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 Received04/03/2002
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/01/2001
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 30, 2009

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH