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

Catalog Number HP054

Device Problems Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/23/2014

Event Type  malfunction  

Event Description

It was reported that before an unknown procedure, the handpiece was plugged into the generator without any instrument plugged onto it and it came up with switch error, two activations detected.This was the second time the handpiece had been plugged in and it was the second time this error came up even though no instrument was attached.Another like device was used to complete the procedure.There were no adverse consequences for the patient.

Manufacturer Narrative

(b)(4) - nose cone.Should the information be provided later, a supplemental medwatch will be sent the handpiece was received with the nose cone damaged and the mount was noted to be loose.It was connected to a generator, evaluated with a test instrument and resulted in "reactivate two switch activations detected" alert screen displayed by the generator.The instrument was disassembled to perform an internal electrical test that revealed a hand activation to ground short circuit condition at the cable level, affecting the functionality of the handpiece.In addition the acoustic isolator was torn and there was moisture evidence.The handpiece has a number of seals to prevent fluids from entering the housing.¿moisture evidence¿ describes a condition where water enters the handpiece cavity during the steam sterilization process.The primary path of ingress is the distal seal, caused by a reduction of compressive force on the distal seal.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.

• 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: janice hinsey ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133373009
• MDR Report Key: 3702306
• MDR Text Key: 16775694
• Report Number: 3005075853-2014-01962
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K002906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2014

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 Number: HP054
• Other Device ID Number: BATCH D9DV9U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/20/2014
• Initial Date FDA Received: 03/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR