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

Catalog Number HARHD36

Device Problem Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was returned with the distal tip of the blade broken off and not returned.The remaining blade portion was scratched, and with evidence of contact with metal in or out of the operative field.This blade tip portion may have broken off of the device during transport to our analysis site.During functional testing on gen11, an alert screen was displayed.A probable cause of the device stopping activation and displaying an alert screen is blade damage.The device was disassembled to inspect the internal components and no anomalies were found.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance were identified.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.Once minor blade damage has occurred, subsequent activations may increase the severity of the blade damage.This in turn can result in activation issues such as failing the pre-run test with the generator and displaying an alert screen.These alert screens that can result include, ¿blade error detected¿ or "relaxed pressure on blade," followed by a ¿replace instrument¿ screen later in the procedure.Continued usage of the damage blade can result in a broken blade.

Event Description

It was reported by the sales rep that, during a laparoscopic gastrectomy, the device suddenly stopped functioning during use.After the procedure, it was found that the gen11 did not turned on.The device was used on the blood vessels.The blade tip was not broken off and no pieces fell into the patient.Gen11 was used.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

• 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: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; 6107428552
• MDR Report Key: 9566780
• MDR Text Key: 193922535
• Report Number: 3005075853-2020-00152
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10705036015055
• UDI-Public: 10705036015055
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2019
• Device Catalogue Number: HARHD36
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Date Manufacturer Received: 12/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1