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

Catalog Number HARHD36

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #r9528y.Investigation summary: 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 stop activating and display an alert screen is blade damage.The device was disassembled to inspect the internal components and no anomalies were found.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 failing the pre-run test with the generator and displaying an alert screen.These alert screens that can result are such as ¿tighten assembly¿, ¿blade error detected¿ or "relaxed pressure on blade" or " removed instrument from patient" followed by a ¿replace instrument¿ screen later in the procedure.Continued usage of the damage blade can result in a broken blade.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

Event Description

While performing a laparoscopic hysterectomy, the hd1000i harmonic stopped working without any reason.It was used normally, with advanced hemostasis button being used very regularly, because the type of structures, but at the vagina/uterus junction approach, the gen11 generator started to present error messages, and hd1000i had to be replaced.Was surgery delayed due to the reported event? yes.If yes, number of minutes: 10 minutes.Action taken when event occurred? harmonic replacement.Was procedure successfully completed? yes.Were fragments generated? no.If yes, were they removed easily without additional intervention? unknown.Patient status/ outcome / consequences: no.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown.Is the patient part of a clinical study? unknown.(b)(4).By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.True.

• 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: 8515938
• MDR Text Key: 142260942
• Report Number: 3005075853-2019-18125
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2023
• Device Catalogue Number: HARHD36
• Device Lot Number: R95538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Date Manufacturer Received: 04/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1