MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI ENERGY; SYNCHROSEAL

Model Number	480440-06
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Material Fragmentation (1261); Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive received the synchroseal to perform failure analysis.Visual inspection found the cut electrode thermally damaged on the jaws.The cut electrode was thermally damaged, and there may be missing pieces; however, the size of the missing pieces cannot be confirmed, indicating that a fragment may have detached from the instrument.The synchroseal instrument was placed on in house system and passed engagement and recognition tests.The seal test was performed and passed all three attempts.The probable root cause may be attributed to either damage during use or the manufacturing process.Damage during use can result from instrument collisions or improper intraoperative cleaning with another instrument.
Event or Problem Description
It was reported that during a da vinci-assisted hysterectomy ¿ benign surgical procedure, three synchrseal within one surgery were defective.After one or two uses, the coating in the jaws came loose and the device displayed an error message.The instrument then became unusable.Repeated error 25913 occured mid procedure.The nurse replaced the syncroseal instrument with a backup synchroseal instrument and the error reoccurred.The clinical sales representative (csr) power cycled e-100 generator, the issue appeared to occur less but it was still occurring.The third synchroseal instrument that was used had the same error occur.The error message displayed that homeostasis was compromised and the sealing process was not successful.Error logs show error 25913 - e-100 error: recoverable error: instrument cut electrodes shorted (p1:0x10000001) / rec-01.The csr stated the instrument branches were not too dirty, not carbonized.The instrument was cleaned and reinserted, but the error persisted.Afterwards, the csr stated that the plastic on the synchroseal instrument appeared as if it was liquified and/or some parts were missing.At the time, it was not clear yet if parts fell into patient.The tse requested photos of the broken instrument including serial numbers and will add the pictures once they arrive.At the time of the call, it was not clear if all instruments were from the same charge of production.The field service engineer (fse) was informed to replace e-100 generator.The case was cloned to the customer support queue to ensure proper handling of incident.The procedure would be completed without bipolar energy from the synchroseal instrument.The customer would not use e-100 generator until clarification.The monopolar energy from erbe generator would be used instead (also different instruments).No fragment fell into the patient.The user completed the procedure and no known impact or patient consequence was reported.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive the da vinci product with an alleged issue to perform failure analysis.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the da vinci product with an alleged issue to perform failure analysis.Upon visual inspection, no issues were found that would be related to the reported event.The e100 generator was installed onto a golden system where it was tested with 10 power cycles and 50 energy cycle cut/seal actions.Reported complaint could not be replicated.Probable root cause is attributed to defective generator.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: DA VINCI ENERGY
• Common Device Name: SYNCHROSEAL
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 25024513
• Report Number: 2955842-2026-23232
• Device Sequence Number: 9140431
• Product Code: NAY
• UDI-Device Identifier: 10886874117306
• UDI-Public: (01)10886874117306(10)K11250116
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K191280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2026

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 Model Number: 480440-06
• Device Catalogue Number: 480440
• Device Lot Number: K11250116 0138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/07/2026
• Supplement Date Received by Manufacturer: 05/06/2026; 06/09/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 05/28/2026; 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Unknown