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

Catalog Number HP054

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information: the hp054 is stating that it has 40+ uses left; however, when we tried to test the hp054 the handpiece was received with the nose cone cracked and the mount was noted to be loose.No functional testing could be performed due to the nose cone was extremely cracked and no instrument could be attached to the handpiece.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.It is possible that due to the wires were disconnected a replace handpiece was displayed.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 record was reviewed and no protocols or ncrs related to the complaint were found during the manufacturing process.

Event Description

It was reported that during an unknown procedure, the handpiece stated that it needed to be replaced and the handpiece could not be used.It is not known how the procedure was completed.There were no patient consequences reported.

• 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: 6286053
• MDR Text Key: 66331380
• Report Number: 3005075853-2017-00597
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• PMA/PMN Number: K002906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2017
• 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: 01/13/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2014
• 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