MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC SCALPEL 5MM HD SHEATH HOOK TIP; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	HDH05
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 3/19/2026.D4 batch #: a97043.Additional information was requested and the following was obtained: ·it was mentioned that "the blade was broken and retrieved." but it is correct in understanding that the broken pieces of the blade fell off inside the patient's body and were all removed? -the doctor commented again that the doctor felt something wrong and the device was removed from the patient's body when the device was used.The tip was broken when the device was operated outside the surgical field.·please tell us how the broken pieces were removed from the patient's body.(for example, the broken pieces were retrieved with forceps under laparoscopy?).-because the damage occurred outside the patient's body, there is no procedure to remove it.·was there any bleeding or tissue damage when this event occurred? (please also let us know if any additional treatment was required.) -no, there was no bleeding or tissue damage.·will the broken pieces be sent with the returned device? -the broken pieces will be sent.Were any fragments generated? -no.The blade was not broken off, it was deformed.Did the fragments generated fell off inside the patient? - no if yes, were they completely removed from the patient without additional intervention? - na what efforts were made to locate the pieces of the blade during the procedure? - na.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 it was returned with the device.The remaining blade portion was scratched and with evidence of contact with metal in or out of the operative field.During functional testing on gen11, an alert screen was displayed.A probable cause for the device to stop activating and the energy system to display an alert screen is blade damage.The device was disassembled to verify the condition of 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 damaged blade can result in a broken blade.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 a97043, and no non-conformances were identified.
Event or Problem Description
It was reported that, during an unknown ob-gyn surgery, the tip was broken.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.

• Brand Name: HARMONIC SCALPEL 5MM HD SHEATH HOOK TIP
• Common Device Name: 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: orla o'mahony ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 24643050
• Report Number: 3005075853-2026-02105
• Device Sequence Number: 16004228
• Product Code: LFL
• UDI-Device Identifier: 10705036002109
• UDI-Public: (01)10705036002109(17)291031(10)A97043
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K990362
• 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
• Report Date (Section B): 03/19/2026

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: HDH05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown