MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; PERMANENT CAUTERY HOOK

Model Number 470183-14

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 04/23/2021

Event Type  Injury  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has not received the permanent cautery hook (pch) instrument to confirm/identify any reportable failure mode(s).A follow-up mdr will be submitted if additional information is received.A review of the instrument log for the pch instrument (470183-14, n11200810-0193) associated with this event has been performed.Per the logs, the instrument was last used on (b)(6) 2021.A review of the provided image is consistent with the alleged complaint of a fragment falling off the instrument.The root cause of the failure mode cannot be confirmed without the returned device.A review of the site's complaint history does not show any additional complaints related to this product.This complaint is being reported based on the following conclusion: it was reported that a fragment was missing from the instrument and could not be located.It is unknown if the fragment fell inside the patient or elsewhere.The robotic procedure was converted to an open surgical procedure to attempt to locate the fragment if it was inside the patient's anatomy.At this time, it is unknown what caused the breakage to occur, and the location of the fragment remains unknown.

Event Description

It was reported that during a da vinci-assisted cholecystectomy surgical procedure, the intuitive surgical, inc.(isi) clinical sales representative (csr) called technical support to report that the customer was experiencing issues on universal surgical manipulator 3 (usm3) with inserting and removing the permanent cautery hook (pch) instrument.When the customer removed the pch, they identified that a portion of the hook (nonmetal portion) by the wrist was missing.The customer then stated they were going to call another operating room (or) staff who was in the room at the time to see if she could provide further details.Or staff was merged into the call and reported that they converted the case to open surgery and were currently looking for the missing piece of the pch, but it was unknown if it separated and was lost in the patient or elsewhere.The technical support engineer (tse) requested the instrument be returned to isi for failure analysis.Isi followed up with the initial reporter and obtained the following additional information: the csr was not onsite, but was made aware of the issue by the scrub tech.The customer inspected the pch instrument prior to use and no damage or issues were noted.The pch had been used prior to the issue without any functional issues.There was no arcing or thermal damage reported.When the customer noticed that the pch was missing a piece, they removed the instrument and converted to open surgery to try to find the fragment in the abdominal cavity.The missing piece was not found.The or staff also searched the or thoroughly, but they could not find it either.It is unknown if the missing piece was lost in the patient or if it was lost elsewhere.The surgeon completed the case via open surgery with no other issues.The csr reported that aside from having to convert the procedure to open surgery, there was no report of patient injury.The csr stated the customer was sent on sunday for a ct scan, however the fragment that fell is a plastic material that would not show up on a scan or x-ray.The instrument will be returned for analysis and an image of the instrument tip was provided.On (b)(6) 2021, isi received voluntary medwatch mw5101096 stating the following: " patient underwent a laparoscopic cholecystectomy with da vinci xi robot.During the surgery, it was noted that there was a catching with the arm and could feel resistance.Robotic hook cautery malfunctioned therefore the robot was rendered incapacitated.It was discovered that the hook cautery had cracked on the proximal clevis and a small piece was unaccounted for.".

• Brand Name: ENDOWRIST
• Type of Device: PERMANENT CAUTERY HOOK
• 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: david wang ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 11861390
• MDR Text Key: 265807368
• Report Number: 2955842-2021-10539
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112311
• UDI-Public: (01)00886874112311(10)N11200810
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470183-14
• Device Catalogue Number: 470183
• Device Lot Number: N11200810 0193
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2020
• 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 Age: 74 YR
• Patient Weight: 138