MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ION; CONTROLLER

Model Number	380707-31
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/08/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an ion endoluminal lung biopsy procedure, bleeding was observed.However, according to the initial reporter, the case went well.No further clinical information was provided.Intuitive surgical inc.(isi) attempted to obtain additional information; however, there was no additional information received from the surgeon.
Additional Manufacturer Narrative
Based on the information provided, the cause of the reported complication cannot be determined.There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred in relation to the reported event.If additional information is received, a follow-up mdr will be submitted.A review of the site's complaint history has been performed and no related complaints have been identified.A review of the site's system logs for the reported procedure date was conducted by a senior failure analysis engineer.There are no logs available for en0043 on 10/08/2020.There are logs available for other dates in october 2020, but none for the event date.No images or videos were shared for the event this complaint is reportable due to the following conclusion: it was alleged that during an ion endoluminal lung biopsy procedure, bleeding was observed.It is unknown what caused the bleeding, if there was any blood loss, or if there was any medical intervention required.

• Brand Name: ION
• Common Device Name: CONTROLLER
• 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: 14780479
• Report Number: 2955842-2022-12286
• Device Sequence Number: 5779988
• Product Code: EOQ
• UDI-Device Identifier: 00886874116241
• UDI-Public: (01)00886874116241
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K182188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/13/2020

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: 380707-31
• Device Catalogue Number: 380707
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2020
• 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