MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI ENERGY; E-100 GENERATOR

Model Number	378848-07
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.The fse was able to reproduce the reported issue and made a configuration adjustment to correct reported problem.The system was verified and ready to use.The complaint was confirmed based on field evaluation.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the e-100 generator did not work.The led on power button was on, but it was not while the instrument was connected.The customer stated that they used the erbe generator with the vessel sealer instrument without any problem.An intuitive surgical, inc.(isi) technical service engineer (tse) viewed the system event logs but did not notice anything relevant.The procedure was completed with no reported injury.Intuitive surgical inc.(isi) followed up with the initial reporter and obtained the following additional information: the e-100 was not working at all.It was a new da vinci system installed.The customer used the erbe generator and were able to use the vessel sealer without any problems.

• Brand Name: DA VINCI ENERGY
• Common Device Name: E-100 GENERATOR
• 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: 19610574
• Report Number: 2955842-2024-15843
• Device Sequence Number: 17732296
• Product Code: NAY
• UDI-Device Identifier: 00886874116982
• UDI-Public: (01)00886874116982
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K191280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/03/2024

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 Model Number: 378848-07
• Device Catalogue Number: 378848
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/27/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• 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: Prefer Not To Disclose