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

Model Number 378848

Device Problem Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted surgical procedure, the e-100 generator was having intermittent issues (red indicator light).The procedure was completed with no reports of patient injury.

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 replaced the e-100 to resolve the reported issue.The system was tested and verified as ready for use.Isi did receive the e-100 involved with this complaint to perform failure analysis.Failure analysis investigation could not replicate the customer reported complaint.The e-100 was installed onto the test system and manually power cycled 5 times.The e-100 powered on with no issue each time.The vessel sealer instrument was installed onto unit with a saline dipped gauze in the jaws.The e-100 was fired with the yellow pedal/sync activation and cut/seal about 100 times.The e-100 worked without any issue.There was no physical damage.

• Brand Name: DA VINCI ENERGY
• Type of Device: E-100 GENERATOR
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 18946375
• MDR Text Key: 338451586
• Report Number: 2955842-2024-12640
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119051
• UDI-Public: (01)00886874119051
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 378848
• Device Catalogue Number: 378848
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2024
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES