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

Model Number 471296-07

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

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

Event Date 03/26/2021

Event Type  Injury  

Manufacturer Narrative

An rma has been issued to the customer requesting to have the large suturecut needle driver instrument returned; however, isi has not received the rma 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 large suturecut needle driver instrument (471296-07/n10201123) 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 into the patient and being retrieved.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 fell into the patient.The fragment was retrieved and no additional surgical intervention was required.However, unintended fragments falling into the patient may require surgical intervention.At this time, it is unknown what caused the breakage to occur.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.

Event Description

It was reported that during a da vinci-assisted hysterectomy surgical procedure, while suturing, the instruments collided causing one side of the tip of the large suturecut needle driver instrument to fall into the patient.The customer had to use fluoroscopy to find the tip, but the tip was retrieved and the patient was not harmed.The procedure was completed with no reported injury.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

Based on a re-evaluation of the complaint information, this complaint has been reclassified as an adverse event and product problem rather than just a product problem, as previously reported.Corrected information can be found the following field: b1, b2, and h1: b1 updated from "product problem" to "adverse event and product problem".B2 updated to "required intervention".H1 updated from "malfunction" to "serious injury".

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Type of Device: LARGE SUTURE CUT 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: david wang ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 11721771
• MDR Text Key: 267880315
• Report Number: 2955842-2021-10435
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874121504
• UDI-Public: (01)00886874121504(10)N10201123
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150284
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471296-07
• Device Catalogue Number: 471296
• Device Lot Number: N10201123 0028
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2020
• 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
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Female