MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC LAP 5MM SHEAR 36CM; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HAR36

Device Problems Difficult or Delayed Activation (2577); Detachment of Device or Device Component (2907)

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

Event Date 03/08/2024

Event Type  malfunction  

Manufacturer Narrative

Pc(b)(4) date sent: 3/25/2024 d4 batch #: unknown attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during an unknown procedure the device was not functional and it showed a detachment in the tip.At the same time the tip began to burn without it being used on the patient.So a second harmonic was requested which was functional.There were no patient consequences.

Manufacturer Narrative

(b)(4) date sent: 4/25/2024 d4 batch #: a9dw1a.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 blade tip damaged, however, the blade was not cracked.The tissue pad was detached and not returned but with evidence of body fluids and tissue pad material in the groove section of the clamp arm.The device was connected to a test handpiece and tested on a gen11.The device did activate when each of the max and min hand activation buttons were depressed, but no continuous activation occurred at any time during functional testing.Additionally, photos were provided and they showed the condition of the reported event.The device was disassembled to verify the condition of the internal components and no anomalies were found.If the device is activated across a clip, staple line, or other metal in the jaws, the blade could get damaged, subsequent activations may increase the severity of the blade damage.Once minor blade damage has occurred 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 ¿tighten assembly¿, ¿blade error detected¿ or "relaxed 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.Based on the condition of the tissue pad, a probable cause for this damage is that the clamp of the device may have been closed and the instrument activated without tissue present.Care should be taken not to apply 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.The resulting damage contributes to the removal of the pad from the clamp arm.The cleaning of the pad, not in accordance with the ifu, can also result in the removal of the pad during use.A manufacturing record evaluation was performed for the finished device batch a9dw1a, and no non-conformances were identified.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: HARMONIC LAP 5MM SHEAR 36CM
• 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: 18970263
• MDR Text Key: 338659219
• Report Number: 3005075853-2024-02372
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10705036014447
• UDI-Public: 10705036014447
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K120729
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HAR36
• Device Lot Number: A9DW1A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR AND HANDPIECE.