MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; PATIENT SIDE CART, 4-ARM

Model Number 380652-48

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); Blood Loss (2597)

Event Date 10/09/2020

Event Type  Injury  

Manufacturer Narrative

Although the patient experienced postoperative bleeding after a da vinci-assisted lobectomy surgical procedure, there is no allegation of an isi device or system malfunction that could have caused, or contributed to the reported incident.The cause of the reported postoperative complication is unknown.A follow-up mdr will be submitted if additional information is received.Isi has reviewed the site's system logs with a procedure date of (b)(6) 2020, and system serial #: (b)(4) no related system errors were found to have occurred during the surgical procedure.In addition, the system logs show that all the instruments used the procedures were used in subsequent procedures, with the exception of the vessel sealer instrument (which is a single-use instrument), and site review confirmed there are no complaints against the instrument.Instrument log: tip up fenestrated grasper instrument (part #470347-11; lot n10200102-0142 had 5 uses remaining out of 10 at the end of the procedure.The instrument was last used (b)(6) 2020.Cadiere forceps instrument (part #470049-06; lot n10200113-0215 had 6 uses remaining out of 10 at the end of the procedure.The instrument was last used on (b)(6) 2020.Fenestrated bipolar forceps instrument (part #470205-17; lot n10191209-0168) had 7 uses remaining out of 10 at the end of the procedure.The instrument was last used (b)(6) 2020.Monopolar curved scissors instrument (part #470179-19; lot n11191209-0043) had 7 uses remaining out of 10 at the end of the procedure.The instrument was used in a subsequent surgical procedure performed on (b)(6) 2020.Curved tip stapler instrument (part #470530-08, lot t11190829-0022 ) had 33 uses remaining out of 50 at the end of the procedure.The instrument was used in a subsequent surgical procedure performed on 06-nov-2020.Stapler 45 instrument (part #47298-12; lot # t10190211-0069) had 30uses remaining out of 50 at the end of the procedure.The instrument was used in a subsequent surgical procedure performed on (b)(6) 2020.Advanced system log investigation: a review of the stapler logs show that the curved tip stapler instrument part number: 470530-08, lot t11190829-0022 fired four white stapler 30 reloads.All firings were completed per the logs.There were no incomplete clamps by this instrument.After the curved tip stapler instrument was used, logs showed that stapler 45 instrument part number: 470298-12, lot t10190211-0069 was installed and fired one blue stapler 45 reload.Firing was complete per logs with no incomplete clamps.Site history review: as of 10-nov-2020, a review of the site's complaint history does not show any additional complaints related to this event.Image/video review: no image or video clip for the reported event was submitted for review.Based on the information provided at this time, this complaint is being reported due to the following conclusion: after undergoing a davinci-assisted lobectomy surgical procedure, the patient underwent another surgical procedure to control the bleeding that was discovered post-operatively.At this time, it is still unknown what caused the post operative bleeding experienced by the patient.

Event Description

It was reported that after a da vinci-assisted lobectomy surgical procedure, 100 ml of blood was identified in the drain.As a result, emergency surgery was performed.The bleeding source was determined as the bronchial artery.The surgeon controlled the bleeding, and the procedure was completed.The following is unknown: timeline of the bleeding and second procedure, how the surgeon obtained hemostasis, what was the estimated blood loss, and the cause of the bleeding.The patient did not require a blood transfusion.The surgeon confirmed that the postoperative complication was not related to da vinci product, and there was no comment on the cause.The surgeon stated that he "overlooked bleeding on x-ray image after the procedure, and this bleeding is seen once in 10 years," therefore he evaluated this event is not related to da vinci.The patient was in the icu for one day after the second surgery and then transferred to a regular room.The patient is reported to be recovering well.There is no allegation of an intuitive surgical, inc.(isi) device or system malfunction that could have caused or contributed to the postoperative complications.The cause of the reported postoperative complication is unknown.Isi made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.

• Brand Name: DAVINCI XI
• Type of Device: PATIENT SIDE CART, 4-ARM
• 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: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 10836523
• MDR Text Key: 216416108
• Report Number: 2955842-2020-11192
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• UDI-Public: (01)00886874110720
• Combination Product (y/n): N
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 380652-48
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2020
• 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
• Patient Outcome(s): Hospitalization; Required Intervention