MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; STAPLER 45

Model Number	410298-12
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the stapler involved with this complaint and completed the device evaluation.Failure analysis investigations did not replicate nor confirm the customer reported complaint.Visual inspection found no damage to the stapler.The instrument was placed on the in-house system, the instrument successfully passed initialization.The instrument clamped and fired with no issues on multiple occasions.A review of the logs show there was several motor pack faults followed by stapler failures, indicating the failure is related to the motor pack and not the stapler.Intuitive surgical, inc.(isi) received the motor pack involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed through error logs the customer reported complaint.A review of error logs showed that the stapler motor pack (smp) experienced a 32070 error when placed with a stapler unit during initialization on system sh0768 on (b)(6) 2020.Error 32070, p1=d0001 current/voltage error¿, occurred with the stapler.Error 3207 stated the stapler motor pack (smp) generated a fault¿.Several in-house staplers were attached successfully on the smp.The instrument control box (icb) indicator light turned blue indicated the unit was recognized.Unit passed self-initialization on multiple attempts and on different arms.No initialization or fault failures occurred during in-house testing.
Event or Problem Description
It was reported that during a da vinci-assisted hemicolectomy (left) surgical procedure, the endowrist stapler 45 fired twice and then stopped working.The procedure was converted to open.Intuitive surgical, inc.(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: ENDOWRIST;DAVINCI SI
• Common Device Name: STAPLER 45
• 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: 17028363
• Report Number: 2955842-2023-15268
• Device Sequence Number: 6973463
• Product Code: NAY
• UDI-Device Identifier: 00886874111093
• UDI-Public: (01)00886874111093(10)T10181026
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K113706
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/28/2020

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: 410298-12
• Device Catalogue Number: 410298
• Device Lot Number: T10181026 270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2018
• 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