MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC HD 1000I SHEARS 36CM SHAFT; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HARHD36

Device Problems Failure to Cut (2587); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: the device was returned with no apparent damage.The device was connected to a gen11 and it was found that the device was functional and worked as intended.Next the device was tested with the test media and performed as expected.However, during functional testing on the generator, although the device did activate, there was no audible feedback sound from the instrument when the clamp arm was fully closed.The instrument was disassembled to inspect internal components and the closure indicator was bent and not making contact with the moving trigger.The amount of energy delivered to the tissue and resultant tissue effects are a function of many factors, including the power level selected, blade characteristics, grip force, tissue tension, tissue type, pathology and surgical technique.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.No conclusion could be reached as to what caused this issue.The batch history record was reviewed, and no defects, nc¿s or protocols related to the complaint, were found during the manufacturing process.

Event Description

It was reported that during an unknown procedure, the click sound was not heard within an hour and the device became not to cut tissue properly.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: HARMONIC HD 1000I SHEARS 36CM SHAFT
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 7770406
• MDR Text Key: 116888004
• Report Number: 3005075853-2018-11967
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 20705036015052
• UDI-Public: 20705036015052
• Combination Product (y/n): N
• PMA/PMN Number: K160752
• 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: 07/31/2018

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: 01/31/2023
• Device Catalogue Number: HARHD36
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/31/2018
• Initial Date FDA Received: 08/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1