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

Model Number	378848
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted gastric bypass (roux-en-y) surgical procedure, the customer reported an issue with the vessel sealer extend (vse).The vse failed and resulted in an abort to open.The intuitive surgical, inc.(isi) technical support engineer (tse) reviewed the logs but found no related issue.The customer had no additional details about the issue as far as the arm it was installed in, whether the vse was used in the e100/iesu, or how exactly the vse failed but the customer has indicated something was wrong and was not going to perform surgery without the system being checked.The procedure was converted to open surgery.
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.The reported event was addressed with phone support.The intuitive surgical, inc.(isi) field service engineer (fse) contacted the customer and was informed that in-service will be provided for best practices for fiber cable usage to the staff.No site visit was conducted.The system was working properly, and no additional action was required as the issue was resolved.

• Brand Name: DA VINCI XI
• Common Device Name: GENERATOR,E-100
• 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: 19191815
• Report Number: 2955842-2024-13521
• Device Sequence Number: 12672763
• Product Code: NAY
• UDI-Device Identifier: 00886874116982
• UDI-Public: 00886874116982
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K191280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/02/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: 378848
• Device Catalogue Number: 378848
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown