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

Catalog Number HARHD36

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/30/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 3/22/2024.D4 batch #: a9dp4r.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.  visual analysis of the returned sample determined that 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.In addition, the device was returned with the tissue pad damaged.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 verify 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 activation issues such as failing the pre-run test with the generator and displaying an alert screen.These alert screens that can result are such as "remove instrument from patient" or ¿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.Probable causes of tissue pad damage are applying pressure between the instrument blade and tissue pad without having tissue between them.Prolonged usage of advanced hemostasis mode may cause tissue pad damage.Keep the clamp arm open when backcutting or while the blade is active without tissue between the blade and tissue pad to avoid damage to the tissue pad.As part of the quality process all devices are manufactured, inspected, and released to approved specifications.  a manufacturing record evaluation was performed for the finished device batch a9dp4r, and no non-conformances were identified.

Event Description

It was reported that during a pancreas procedure the tissue pad melted.Changed to another device to complete surgery.There was no patient consequence reported.No additional information can be provided.

• 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: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 18961791
• MDR Text Key: 338386218
• Report Number: 3005075853-2024-02342
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10705036015055
• UDI-Public: 10705036015055
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K160752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HARHD36
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2024
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: GENERATOR.