MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC ACE ADAPTIVE TISSUE TECHNOLOGY; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HAR36

Device Problems Break (1069); Detachment Of Device Component (1104); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/28/2014

Event Type  malfunction  

Event Description

It was reported that during an procedure the first har36 was used but the blade sheared off.Second har36 was opened and changed the handpiece but still no resolution.Third har36 was opened to complete the procedure.No adverse event to the patient.Delay of 40 minutes.The user was trained.The product was stored according to labeling instructions.

Manufacturer Narrative

(b)(4).When additional information is received and/or the device analysis has been completed, a supplemental medwatch will be sent.

Manufacturer Narrative

(b)(4).The device was returned with the distal tip of the blade broken off and it was returned with the device.The remaining blade portion was scratched, evidence of contact with metal in or out of the operative field.The device was functionally tested with a generator.During functional testing on gen11 an alert screen was displayed.A probable cause of the device stop activating and display an alert screen is blade damage.Probable causes of blade damage, including breakage, are external contact during pre-op or general use, blade contact with other devices, staples or clips during the procedure or using any means other than the blade wrench to attach or detach the blade.Once minor blade damage has occurred, subsequent activations may increase damage severity and result in alert screens, such as ¿tighten assembly¿, ¿blade error detected¿ or "relaxed pressure on blade" followed by a ¿replace instrument¿ screen later in the procedure.

• Brand Name: HARMONIC ACE ADAPTIVE TISSUE TECHNOLOGY
• 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: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 3749013
• MDR Text Key: 4483711
• Report Number: 3005075853-2014-02550
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K120729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/30/2014

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 Expiration Date: 09/25/2018
• Device Catalogue Number: HAR36
• Device Lot Number: UNKNOWN
• Other Device ID Number: BATCH K92H42
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/16/2014
• Initial Date FDA Received: 04/14/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR, HANDPIECE