MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; LARGE NEEDLE DRIVER

Model Number 471006-12

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/09/2022

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the causes of the customer reported failure mode and the patient¿s intra-operative complication are unknown.Isi has attempted to contact the site to gather additional information regarding the patient/incident.However, as of the date of this report, no new information has been obtained.Isi has not received the large needle driver instrument involved with this complaint.A follow-up mdr will be submitted if the instrument are returned (post failure analysis evaluation) or if additional information is received.A review of the system and instrument logs has been performed.There were no observed events in the available system logs that would suggest a product issue, and logged events are in line with normal system functionality.No image or video clip for the reported event was submitted for review.No additional technical review was required based on the complaint.This complaint is being reported due to the following conclusion: during a da vinci-assisted sacrocolpopexy procedure, the large needle driver instrument was found to be "stuck" and there was a 20-minute delay to remove the instrument.As a result, hemostasis in the patient could not be controlled.At this time, the cause of the uncontrolled bleeding, the severity of the bleed, and what medical intervention was administered (if any) as a result of the intra-operative complication are unknown.

Event Description

It was reported that during a da vinci-assisted sacrocolpopexy procedure, the large needle driver instrument was "stuck" in the patient.There was no tissue attached to the instrument at the time of removal.There was a 20-minute delay in removing the instrument.The e-stop button was reportedly pressed.According to the initial reporter, hemostasis could not be controlled.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.

Manufacturer Narrative

On 13-jun-2022, intuitive surgical, inc.(isi) received the following additional information from failure analysis of the instrument: isi has received the large needle driver instrument associated with this complaint and completed investigations.Failure analysis investigations confirmed the customer reported complaint.The instrument was found to have one input disk broken and another one cracked.Input disk #6 was found completely detached from the base of the housing.Hairline cracks were found on grip input shafts.The root cause of broken instrument input disks is typically attributed to mishandling/misuse, most commonly caused by improper cleaning/reprocessing techniques.Additional observation not reported by site: the instrument was found to have a broken grip cable at idler pulleys.The idler pulleys at the proximal clevis spun freely and did not exhibit any damage.There was no damage found on the proximal clevis or cable hole.The instrument housing was removed and found that the hypotube was wrapped around the clamping pulley of input disk #6 due to the broken grip cable.The root cause of broken distal instrument grip cables is attributed to a component failure.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Type of Device: LARGE NEEDLE DRIVER
• 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: 13830816
• MDR Text Key: 292736052
• Report Number: 2955842-2022-10667
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119754
• UDI-Public: (01)00886874119754(10)N10210628
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/18/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 471006-12
• Device Catalogue Number: 471006
• Device Lot Number: N10210628 0163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 02/18/2022
• Initial Date FDA Received: 03/20/2022
• Supplement Dates Manufacturer Received: 06/13/2022
• Supplement Dates FDA Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2021
• 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
• Patient Sex: Female