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

Catalog Number	HARHPGR
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure the handpiece does not work even after changing ultracision clamp "(41 uses) test x2".
Additional Manufacturer Narrative
(b)(4).Date sent: 4/8/2026.D4 batch #: y7056d.Additional information was requested and the following was obtained: were there any patient consequences? if yes, which ones? no 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 returned with no apparent damage.It was connected to a generator, evaluated with a test instrument and the hand activation feature was non-functional.However, it worked properly with footswitch assembly.No communication issues were observed at any time during the testing.The instrument was disassembled to perform an internal electrical test that revealed a hand activation open circuit condition at the cable level, affecting the functionality of the handpiece.Also, 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.No conclusion could be reached as to what could have caused this issue.Although no conclusion could be reach on the cause of the reported event.It is probable that the ingress of moisture affected handpiece functionality.

• 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: 24816879
• Report Number: 3005075853-2026-02640
• Device Sequence Number: 20369902
• Product Code: LFL
• UDI-Device Identifier: 20705036023422
• UDI-Public: (01)20705036023422
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K002906
• 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): 04/08/2026

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: HARHPGR
• Device Lot Number: Y7056D081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2024
• 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
• Patient Sex: Unknown