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

Catalog Number	HPBLUE
Medical Device Problem Codes	Crack (1135); Failure to Read Input Signal (1581); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 8/5/2024.D4 batch #: a9az6g.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.Additional information was requested and the following was obtained: did the patient experience any adverse consequences due to this issue? [ans: no further updates from nurse/ surgeon regarding on this issue.] 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 a visual blemish in the connector pins and a dry body fluid at the gold rings area.It was connected to a generator, evaluated with a test instrument, and was found to be functional.Additionally, photos were provided and they showed the condition of the reported event.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 lot/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.
Event or Problem Description
It was reported that during a thyroidectomy the surgeon was using this hpblue with har9f at first which it went well.Suddenly the har9f could not be activated.Thus he decided to change another cable with the same har9f to continue the surgery.The procedure was delayed.The nurse tried to use this cable with the same har9f after case, which giving same error message.Salesman went on-site to check the cable and found there's abnormal situation with the cable.The 7 pins where to connect with adapter go darken (look like covering with black dust) which is different from the shinny pins we usually see with cable.Salesman also found there's a black metallic/plastic fragment at the connecting area with consumables.Salesman tried to connect it with gen11 and underwent handpiece testing, however it popped out with 'reactive' 'two switch activating detected' and could not pass the testing.

• 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: 19911495
• Report Number: 3005075853-2024-05693
• Device Sequence Number: 7136393
• Product Code: LFL
• UDI-Device Identifier: 10705036002154
• UDI-Public: 10705036002154
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 08/05/2024

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 Catalogue Number: HPBLUE
• Device Lot Number: A9AZ6G057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2023
• 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