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

Catalog Number	HARHPGR
Medical Device Problem Codes	Failure to Read Input Signal (1581); Use of Device Problem (1670); Appropriate Device Problem Term/Code Not Available (3191); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 9/15/2025.D4 batch #: unknown.Additional information was requested and the following was obtained: did the patient experience any adverse consequences due to this issue? the patient could not be operated by laparoscopy.It was necessary to go to minilaparotomy what is meant by "they cut the patient completely instead of working in a celio"? was the surgical procedure converted to open? yes.When connecting the handpiece to the ultracision generator it tells us handpiece to change.Change handpieces 3 times with always the same message.Test with our 2 other generators and always the same message.Change of single-use scissors without success.Plugging into another power outlet does not change anything.Unable to operate any of our 3 ultracision generators, the decision is made to take care of the patient by minilaparotomy instead of the planned laparoscopy.More invasive patient management than expected.Attempts are being made to obtain the following information.To date, no response has been provided.If further details are received at a later date, a supplemental medwatch will be sent: were any of the devices used prior to orange message appearing? what was the reasoning behind the conversion to minilaparotomy? did the device issues cause or contributed to the conversion to the minilaparotomy? attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.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 the procedure, as soon as the handpieces were connected to the scissors, an orange message appeared saying "no more use left." instead of proceeding, they cut the patient completely instead of working in a celio.They used three handpieces to complete the operation.No more information available.
Additional Manufacturer Narrative
(b)(4).Date sent: 9/23/2025.Corrected data: h6 medical device problem code.Additional information was requested and the following was obtained: were any of the devices used prior to orange message appearing? none of the devices could be used that day, all caused the orange message to appear before they could be used.What was the reasoning behind the conversion to minilaparotomy? unable to work with any of the handpieces and any of the generators, there was no choice but to resort to open surgery.Did the device issues cause or contributed to the conversion to the minilaparotomy? it is therefore the problem related to unusable devices that led to the conversion of the mode of surgery.
Additional Manufacturer Narrative
(b)(4).Date sent: 11/3/2025.An analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/22/2025.Corrected data: h6 medical device problem code.Additional information was obtained: a cross-functional meeting was held on december 10, 2025, to discuss this complaint.It was confirmed that a har736 was originally used in the procedure and was used for a period of time.An orange error message occurred, and troubleshooting was initiated.The operating team tried 2 additional gray handpieces, an additional har736, and 2 additional generators to troubleshoot the issue and kept receiving the orange screen.The rep confirmed that during the troubleshooting they tried the same handpiece and disposable on all 3 generators, which locked the device.During the course of troubleshooting, they locked out the only two har736 devices they had.Subsequently.They connected two more handpieces with replace instrument faults as a result of locking out the disposable devices previously.The rep then used a demo device on all 3 handpieces and determined that only 1 handpiece was defective.The other 2 were functioning as intended.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/14/2026.Corrected data: h6 medical device problem code.

• Brand Name: HARMONIC GREY HAND PIECE
• 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: orla o'mahony ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 23052334
• Report Number: 3005075853-2025-07297
• Device Sequence Number: 13155132
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: HARHPGR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/26/2025
• Supplement Date Received by Manufacturer: 09/11/2025; 10/30/2025; 12/10/2025; 01/12/2026
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 09/23/2025; 11/03/2025; 12/22/2025; 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown