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	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during laparoscopic cardiovascular surgery, the root part of the device had heat excessively and was melted.The device was used as usual.Gen11 was used.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/5/2024.D4 batch #: u93643.Investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that the device was received with thermal damage to the outer sheath of the blade in the clamping area.Due to the returned condition of the device, no functional testing could be performed with the generator.This damage could have resulted from not torquing the instrument properly to the handpiece, resulting in excessive heat generation.Please reference the instruction for use for more information.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 u93643, and no non-conformances were identified.

• 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: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 19049913
• Report Number: 3005075853-2024-02632
• Device Sequence Number: 15573969
• Product Code: LFL
• UDI-Device Identifier: 10705036002109
• UDI-Public: 10705036002109
• 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,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/05/2024

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 Expiration Date: 12/31/2024
• Device Catalogue Number: HDH05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2024
• Initial Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR.
• Patient Sex: Unknown