MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; TIP-UP FENESTRATED GRASPER

Model Number 470347-11

Device Problem Entrapment of Device (1212)

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

Event Date 03/25/2022

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the tip-up fenestrated grasper involved with this complaint and completed the device evaluation.Failure analysis investigations did not replicate nor confirm the customer reported complaint.Visual inspection was performed and no gap was observed between the main tube and the proximal clevis.No damage was observed.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The grips/tips (for scissors) opened and closed properly.The instrument was fully functional.Additional observation not reported by site was that the instrument was found to have various scratch marks removed on the main tube.The scratch marks were 0.076¿ - 0.156¿ in length and were not aligned with the tube axis.The root cause is typically attributed to mishandling/misuse.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No image or video clip for the reported event was available for review.A review of the device logs for the tip-up fenestrated grasper (part# 470347-11 | lot/serial# (b)(4)) associated with this event has been performed.Per this review of the logs, the tip-up fenestrated grasper was last used on (b)(6) 2022 via system serial# (b)(4).There were 7 uses remaining after this last usage.This complaint is being reported based on the following conclusion: it was reported that tissue was caught in the instrument's wrist.Medical intervention may be required in the event that an moving instrument mechanism within an instrument entraps tissue and causes damage.At this time, it is unknown what caused the device entrapment issue 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 pulmonary lobectomy surgical procedure, the tip-up fenestrated grasper had a gap between the instrument shaft and wrist joint where the patient's tissue got caught.There was no damage to the tissue.The customer discontinued use of the instrument and replaced with a backup instrument.The procedure was completed as planned with no reported injury.Intuitive surgical, inc.(isi) followed up with the clinical sales representative (csr) and a doctor and obtained the following additional information: it was unknown if the instrument was inspected prior to use.The patient did not experience any intra-operative complications or post-operative complications.The tip-up fenestrated grasper instrument was not grasping a tissue when the issue occurred; however, the customer noted that a lung tissue got stuck at the joint part of the wrist.The tissue eventually came off without requiring any further action from the user.The surgeon does not think a da vinci system, instrument, and/or accessory malfunction occurred.This event did not impact the procedure according to the surgeon.No photographic images of the device or video recording of the procedure were available for review.Information regarding patient demographics, relevant testing, and medical history was requested, however the reporter was not able to provide that information.

• Brand Name: ENDOWRIST
• Type of Device: TIP-UP FENESTRATED GRASPER
• 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: 14221513
• MDR Text Key: 290187141
• Report Number: 2955842-2022-11261
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112496
• UDI-Public: (01)00886874112496(10)N10200706
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470347-11
• Device Catalogue Number: 470347
• Device Lot Number: N10200706 0200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2022
• Date Manufacturer Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2020
• 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
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES