MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC 700 SHEARS 45CM; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	HAR745
Medical Device Problem Codes	Material Separation (1562); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, at the end of the myomectomy operation, the active branch broke off.According to the user, the generator emitted a different sound before the branch broke.It is not clear whether the broken part was removed as a suction cup was used during surgery.
Additional Manufacturer Narrative
(b)(4).Date sent: 11/6/2024.D4 batch #: unknown attempts are being made to obtain the following information.To date, no response has been provided.If further details are received at a later date, a supplemental medwatch will be sent: what efforts were made to locate the pieces of the blade during the procedure? are there any plans to locate the pieces? was there any change in the patient care as a result of this event? what is the current patient status? ¿did the patient experience any adverse consequences due to this issue? were there any device issues or alert screens prior to the broken blade tip? 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.
Additional Manufacturer Narrative
(b)(4).Date sent: 11/18/2024.Corrected data: h6 medical device problem code.Additional information was requested and the following was obtained: what efforts were made to locate the pieces of the blade during the procedure? suction.Are there any plans to locate the pieces? no.Was there any change in the patient care as a result of this event? patient has been informed - other wise nothing has been changed.What is the current patient status? no information.Did the patient experience any adverse consequences due to this issue? according the surgeon not.Were there any device issues or alert screens prior to the broken blade tip? according to the assistant doctor, there was a whistling noise from the generator beforehand.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/17/2024 d4 batch #: y70023 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 shaft bent.During functional testing on gen11, an alert screen was displayed.A probable cause for the device to stop activating and the gen11 to 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 or using any means other than the blade wrench to attach or detach the blade.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 ¿tighten assembly¿, ¿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.The damaged on the shaft is related to improper use of the device.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 y70023, and no non-conformances were identified.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/9/2024.The device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.

• Brand Name: HARMONIC 700 SHEARS 45CM
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): JABIL (TAJUANA)
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 20621217
• Report Number: 3005075853-2024-08407
• Device Sequence Number: 12988148
• Product Code: LFL
• UDI-Device Identifier: 10705036035787
• UDI-Public: (01)10705036035787(17)281231(10)Y70023
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K221790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: HAR745
• Device Lot Number: Y70023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: 11/07/2024; 11/25/2024; 12/09/2024
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 11/18/2024; 12/09/2024; 12/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2024
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HANDPIECE AND GENERATOR.
• Patient Sex: Unknown