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

Model Number	HDH05
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: x9581r.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.A manufacturing record evaluation was performed for the finished device batch 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 or Problem Description
It was reported that, during laparoscopic myomectomy, it was found that the pin came off.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: 4/6/2023.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 retention pin missing and not returned.The blade tip was not broken off as reported by the customer.Due to the condition of the returned device, we were unable to test on the gen11.No conclusion could be reached as to what caused the retention pin missing.Due to this condition the event reported is confirmed.As part of the quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.

• 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
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 16505287
• Report Number: 3005075853-2023-01357
• Device Sequence Number: 6221132
• 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,Followup
• Report Date (Section B): 03/08/2023

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 Model Number: HDH05
• Device Catalogue Number: HDH05
• Device Lot Number: X95E16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2023
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2022
• 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: HANDPIECE AND GENERATOR.
• Patient Sex: Unknown