MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST LARGE HEM-O-LOK CLIP APPLIER

Model Number 470230-12

Device Problem Unintended System Motion (1430)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/12/2021

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted cholecystectomy surgical procedure, the large hem-o-lock clip applier wrist was turning without the surgeon navigating it, also the white disc is popping out. The procedure was completed with no reported injury. Intuitive surgical, inc. (isi) followed up with the initial reporter and obtained the following additional information: the reporter clarified that by "white disc", they meant the input disc on housing end that is responsible for manipulation the instrument. There were no issues noted prior to use. The customer removed the instrument and completed the procedure using a spare. There was no report of patient injury. No further details/information available.

Manufacturer Narrative

The large hem-o-lock clip applier instrument has been returned and evaluated by the failure analysis team. Failure analysis investigations replicated/ confirmed the customer reported complaint "white disc is popping out. " but could not replicate or confirm "wrist turning without surgeon navigating it. " failure analysis found the primary failure of broken input disk to be related to the customer reported complaint. The instrument was found to have an input disk broken. Input disk # 6 was found completely detached from the base of the housing. Hairline cracks were found on grip input shafts. No damage to the distal end was observed. The root cause of this failure is attributed to mishandling/ misuse. Failure analysis found the secondary failure of failed engagement to be related to the customer reported complaint. The instrument failed mechanical engagement when placed in the system. Instrument inputs failed to engage with the sterile adapter in multiple attempts. This failure is likely due to the broken input disk observed. As a result of the failed engagement and the broken input disk, functional testing of the device in an attempt to replicate the report complaint is not possible due to the returned condition of the device. There were no engagement failures found during log review. A review of the site's complaint history does not show any additional complaints related to this product or this event. No image or procedure video was provided for review. A review of the instrument log for the large clip applier instrument (470230-12/n11200406-0208) associated with this event has been performed. Per the logs, the instrument was last used on (b)(6) 2021. This complaint is being reported based on the following conclusion: it was alleged that the large clip applier moved freely with uncontrolled motions with no evidence or claim of user mishandling or misuse. Poor instrument control could result in unintuitive motion and subsequent tissue damage. While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur. Follow-up was attempted, but the missing patient information was either unknown, unavailable, not provided, or not applicable. The expiration date is not applicable. The product is not implantable. It is unknown if the initial reporter submitted a report to the fda.

• Brand Name: ENDOWRIST
• Type of Device: LARGE HEM-O-LOK CLIP APPLIER
• 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: 12993279
• Report Number: 2955842-2021-11735
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112380
• UDI-Public: (01)00886874112380(10)N11200406
• 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
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 470230-12
• Device Catalogue Number: 470230
• Device Lot Number: N11200406 0208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2021
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2020
• 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 Sex: No Answer Provided
• Patient Treatment(s): DA VINCI INSTRUMENTS AND ACCESSORIES