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

Model Number HARHD36

Device Problem Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #t94f9h.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 had evidence of contact with metal in or out of the operative field.In addition, the tissue pad was damaged, melted, and 100% present.This blade tip portion may have broken off of the device during transport to our analysis site.During functional testing on a gen11, an alert screen was displayed.A probable cause for the device to stop activating and to display an alert screen is blade damage.Then the device was disassembled to inspect the internal components and no anomalies were found.A manufacturing record evaluation was performed for the finished device lot/batch number and no non-conformance's were identified.Probable causes of blade damage, including breakage, are external contact during pre-op or general use, blade contact with other devices, contact with staples or clips during the procedure.Once minor blade damage has occurred, subsequent activation may increase the severity of the blade damage.This, in turn, can result in the device failing the pre-run test with the generator and displaying an alert screen.The alert screens that can result may include ¿tighten assembly,¿ ¿blade error detected,¿ or "relax pressure on blade," followed by a ¿replace instrument¿ screen later in the procedure.Continued usage of the damaged blade can result in a broken blade.Probable causes of tissue pad damage are applying pressure between the instrument blade and tissue pad without having tissue between them.Keep the clamp arm open when back cutting or while the blade is active, without tissue between the blade and tissue pad, to avoid damage to the tissue pad.Attempts are being made to obtain the following information: did the patient experience any adverse consequences due to this issue? to date, no response has been provided.If further details are received at a later date, a supplemental medwatch will be sent.

Event Description

It was reported that during an unknown procedure, the device jaws did not cut and coagulate after initial activation.Patient consequence was not reported.No additional information is available at this time.

• 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 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 9753521
• MDR Text Key: 202945047
• Report Number: 3005075853-2020-01237
• 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,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HARHD36
• Device Catalogue Number: HARHD36
• Device Lot Number: T94H1X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Date Manufacturer Received: 01/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1