MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC BLUE HAND PIECE; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	HARHPBL
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the handpiece failed shortly after start of the thyroid procedure.The handpiece still has 53 inserts.They tried it twice, took everything apart, shut down gen and tested again.No patient harm nor significant delay reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/20/2024.D4 batch #: w7006x.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 revealed that the device was received with no apparent damage.It was connected to a generator, evaluated with a test instrument, and was found to be non-functional.The handpiece was disassembled to verify the condition of the internal components,.The moisture indicator was positive.The handpiece has a number of seals to prevent fluids from entering the housing."positive moisture indicator¿ describes a condition where water enters the handpiece cavity during the steam sterilization process.The primary path of ingress is the distal seal, this may be caused by a reduction of the compressive force on the distal seal.However, no definitive root cause could be drawn.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.As part of the quality process all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reach on the cause of the reported event.It is probable that the ingress of moisture affected handpiece functionality.

• Brand Name: HARMONIC BLUE HAND PIECE
• 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: 20018991
• Report Number: 3005075853-2024-06159
• Device Sequence Number: 7476719
• Product Code: LFL
• UDI-Device Identifier: 20705036023446
• UDI-Public: (01)20705036023446
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K063192
• 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): 08/20/2024

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: HARHPBL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GENERATOR
• Patient Sex: Unknown