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

Catalog Number HARHD36

Device Problems Loss of Power (1475); Failure to Calibrate (2440)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # p93x3h.Investigation summary the device was returned with no apparent damage.The device was connected to a gen11 and functionality tested.An alert screen was displayed and no further functional testing could be performed.The blade could not be functionally tested due to the returned condition of the instrument.No communication issues were noted during the analysis of the device.The device was analyzed, and it was determined that it was used in more than one generator.The device is intended to be used with a single generator.If the device is connected to a different generator an alert screen will be displayed indicating to replace the instrument / no instrument uses remaining.The device was disassembled and it was found that there was a cracked internal component.No conclusion could be made as to how the component was damaged.This device is packaged and sterilized for single use only.Multiple patient use may compromise the device integrity or create a risk of contamination that, in turn, may result in patient injury or illness.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.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 during a laparoscopic sigmoidectomy, the generator was automatically powered off when the device was on the mayo table.The generator was restarted but it did not recognize the device.The second device was used but the same event continued before the device was used for the patient.The device was used on the blood vessels.The blade tips of two devices were not broken off and no pieces fell into the patient.Gen11 was used.Another third 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: 7390339
• MDR Text Key: 104271447
• Report Number: 3005075853-2018-08826
• 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: foreign
• Type of Report: Initial
• Report Date: 03/11/2018

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: 09/30/2022
• Device Catalogue Number: HARHD36
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2018
• Initial Date Manufacturer Received: 03/11/2018
• Initial Date FDA Received: 04/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1