MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC* BLUE HAND PIECE AND BLUE TEST TIP

Catalog Number HPBLUE

Device Problems Loose or Intermittent Connection (1371); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # m91y8u.The handpiece was received with the mount loose.It was connected to a generator, evaluated with a test instrument and was found to be functional.The instrument was disassembled to inspect the internal components.The moisture indicator was positive.The handpiece has a number of seals to prevent fluids from entering the housing."positive moisture indicator¿ describes a condition where water enters the handpiece cavity during the steam sterilization process.The primary path of ingress is the distal seal; this may be caused by a reduction of the compressive force on the distal seal.However no definitive root cause could be drawn.Due to the condition of the mount, moisture entered the hand piece mid housing.It is probable that the ingress of moisture affected handpiece functionality.The batch history records were reviewed with no anomalies noted during the manufacturing process.

Event Description

It was reported that during an unknown procedure, the message 'na handpiece' was displayed instead of the counter of the hpblue although the device was connected.And the screw part of the device was loose.No pieces fell into the patient.Another device was used to complete the case.There were no adverse consequences to the patient.

Manufacturer Narrative

(b)(4).The handpiece was received partially disassembled from the initial analysis.The handpiece appears to be in good physical condition.Epoxy was found inside the handpiece housing, it appears that the nose cone exposy has migrated and allowed moisture inside the handpiece housing.Visual inspection confirms the initial analysis results.

• 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: 5675623
• MDR Text Key: 45786384
• Report Number: 3005075853-2016-02946
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063192
• 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,Followup
• Report Date: 04/11/2016

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: HPBLUE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/28/2016
• Initial Date FDA Received: 05/24/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1