• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ULTRACISION** HARMONIC SCALPEL** HAND PIECE; INSTRUMENT, ULTRASONIC SURGICAL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ETHICON ENDO-SURGERY, LLC. ULTRACISION** HARMONIC SCALPEL** HAND PIECE; INSTRUMENT, ULTRASONIC SURGICAL Back to Search Results
Catalog Number HP054
Device Problems Loose or Intermittent Connection (1371); Sticking (1597)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/18/2015
Event Type  malfunction  
Event Description
It was reported that the threaded stud is loose and the harh36 disposable device became stuck on the hand piece while setting up for a lavh.Customer used a second handpiece and dispoable to complete the procedure.No patient consequences.
 
Manufacturer Narrative
(b)(4).The handpiece was received attached to a harh36 disposable device.The handpiece was forcibly removed from the disposable and the nose cone was cracked and the mount was noted to be loose.Upon visual inspection no anomalies were found with the threaded of the stud as reported in the event description.No functional testing could be performed due to the nose cone was extremely cracked and no instrument could be attached to the handpiece.However, the handpiece was connected to the generator and ¿no uses remaining - replace hand piece¿ alert screen was displayed by the generator.The instrument was disassembled to inspect internal components.The moisture indicator was positive.The transducer assembly was not held in place due to the cracked nose cone, so torquing on the disposable resulted in twisting only the handpiece transducer assembly until the internal wires got disconnected.Due to the cracked nose cone, moisture entered the hand piece mid housing.A possible cause of the nose cone being cracked is the sterilization method due to the heating and cooling of the sterilization cycles is a stressor.It is possible that the ingress of moisture affected handpiece functionality.The batch history records were reviewed with no anomalies noted during the manufacturing process.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of Device
INSTRUMENT, ULTRASONIC SURGICAL
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo PR 0096 9
Manufacturer (Section G)
ETHICON ENDO-SURGERY, LLC
475 calle c
guaynabo PR 0096 9
Manufacturer Contact
milton garrett
4545 creek road ml 120a
cincinnati, OH 45242
5133378865
MDR Report Key4955757
MDR Text Key6190084
Report Number3005075853-2015-04837
Device Sequence Number1
Product Code LFL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K002906
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 05/18/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberHP054
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/29/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/29/2015
Initial Date FDA Received07/31/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/15/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
GENERATOR AND DISPOSABLE
-
-