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

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.

• 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 Key: 4955757
• MDR Text Key: 6190084
• Report Number: 3005075853-2015-04837
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002906
• Number of Events Reported: 1
• 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 Number: HP054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/29/2015
• Initial Date FDA Received: 07/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: GENERATOR AND DISPOSABLE