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); Failure to Disconnect (2541)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # w90u76.The handpiece was received attached to an har23.The handpiece was forcibly removed.The nose cone was 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 acoustic isolator was torn.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 record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

Event Description

It was reported that before an unknown surgery, the har23 was not activated after setting to the hp054 and connecting to the generator.When the har23 intended to be removed from the hp054, they were not able to be disassembled.The device was not used for the patient.The blade tip was not broken off and no pieces fell into the patient.Another device was used to complete the case.There were no adverse consequences to the patient.

• Brand Name: ULTRACISION HARMONIC SCALPEL HAND PIECE
• 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: 5886897
• MDR Text Key: 52675541
• Report Number: 3005075853-2016-04646
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 07/12/2016

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/02/2016
• Initial Date FDA Received: 08/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2013
• 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