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

Catalog Number HP054

Device Problems Failure to Power Up (1476); Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The handpiece was received attached to a harh36 shaft.The handpiece was forcibly removed from the disposable and the handpiece got disassembled.Upon visual inspection it was observed that the nose cone was cracked and the acoustic isolator was torn.Due to the condition of the device, no functional test could be performed.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.The end cap was disassembled to inspect remaining components and it was found that the moisture indicator was positive.In addition, degradation of the hand activation wire outer jacket was observed.Due to the cracked nose cone, moisture entered the hand piece mid housing.¿positive moisture indicator¿ describes a condition where water enters the handpiece cavity during the steam sterilization process due to the damaged nose cone.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.The batch record was reviewed and no anomalies were noted during the manufacturing process.

Event Description

It has been reported that during an unknown procedure, the handpiece had been used with the disposable device and was not working.Indeed, after screwing the two pieces together it was not activating and no error message appeared.Finally the two devices can not be taken apart.

• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 5525941
• MDR Text Key: 41528776
• Report Number: 3005075853-2016-01643
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K002906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/20/2016

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/07/2016
• Initial Date FDA Received: 03/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2013
• Type of Device Usage: Reuse
• Patient Sequence Number: 1