MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; MONOPOLAR CURVED SCISSORS

Model Number 470179-19

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/02/2021

Event Type  Injury  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has not yet received the monopolar curved scissors (mcs) instrument for failure analysis.Therefore, the root cause of the customer reported failure could not be determined.A procedure video was not submitted to isi for review.A follow-up mdr will be submitted if the instrument is returned (post failure analysis evaluation) or if additional information is received.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.A review of the instrument log for the mcs instrument (part # 470179-19, lot # n11200309 0083) associated with this event has been performed.Per logs, the instrument was last used on (b)(4) 2021 on system (b)(4).Per logs, the instrument had 3 uses remaining.A review of the submitted images confirmed that the orange surface of the mcs instrument was protruding which is consistent with the customer's allegation.It was also confirmed that several instrument wires at the distal end of the mcs instrument were damaged through image review which is consistent with the customer's claim of cutting the instrument wire to remove the instrument from the cannula.The endowrist monopolar curved scissors is intended to be used with the da vinci system for endoscopic manipulation of tissue, including: cutting, blunt and sharp dissection, electrocautery.The instrument is designed to provide energy from the designated location on the instrument (the tip) to the planned anatomical location when used as intended.The energy is activated by pressing the designated pedal on the surgeon side console (ssc).This complaint is being reported based on the following conclusion: it was reported that during a da vinci-assisted radical cystectomy with ileal conduit surgical procedure, the mcs instrument got caught on the tip of the cannula and could not be removed.The customer cut the mcs instrument wire to straighten the wrist and remove the instrument from the cannula.Upon removal damage was found on the section of the instrument shaft colored orange.Fragments possibly fell inside the patient and were not found.At this time, the location is unknown and it is unclear if any fragments actually fell inside the patient and were retained.In addition, the root cause of the customer reported failure mode remains unknown.Blank mdr fields: follow-up was attempted, but the patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.Device expiration date was left blank as this instrument has 10 usages allotted to it, which are tracked by the da vinci surgical system.The instrument has 3 remaining usable lives, therefore, had not expired.The product is not implantable.

Event Description

It was reported that during a da vinci-assisted radical cystectomy with ileal conduit surgical procedure, when the customer tried to remove the monopolar curved scissors (mcs) instrument, the instrument got caught on the tip of the cannula and could not be removed.The customer stated that upon looking at the tip with the camera, it was noted that the mcs tip cover accessory was greatly displaced and since an alert went off during instrument removal, the customer could not straighten the instrument wrist from the console.The customer also stated that the mcs tip cover accessory and instrument wrist were stuck and could not be removed from the port so the entire port was removed.According to the customer, when the mcs tip cover accessory was removed, the section of the instrument shaft colored orange was found to be protruding.Since the instrument tip reportedly could not be straightened manually and could not be pulled out from the cannula, the site decided to cut the instrument wire to straighten the instrument wrist and remove the instrument from the cannula.The doctor stated that it is unlikely that broken pieces from the orange part of the instrument fell into the body since that part of the instrument was covered with the mcs tip cover accessory.However, due to what happened, they could not confirm that fragments did not fall inside the patient because they do not know what was happening inside the patient's body, and it was unclear if the mcs tip cover accessory was in place to retain any possible fragments when the orange section was damaged.Intuitive surgical, inc.(isi) followed up with the site and obtained the following additional information regarding the reported event: the instrument was inspected prior to use and found no abnormality.The isi clinical sales representative (csr) verified that the issue happened during patient side cart (psc) rollout and there was no procedure conversion.The procedure was completed using the same da vinci system.No known impact or patient consequence was confirmed.No troubleshooting performed with dvstat.No post-operative tests were performed.Additionally, the assistant surgeon reviewed the procedure video noted a low possibility that a fragment falling into the patient.No post-operative complication has been reported as of the date of this report.

Manufacturer Narrative

D02, d11: intuitive surgical, inc.(isi) received the monopolar curved scissors (mcs) instrument involved with this complaint and completed the device evaluation.The reported event was confirmed through failure analysis investigation.Initial inspection identified a broken tube extension at the distal end of the instrument.The broken piece measuring approximately 0.146¿ x 0.153¿ was returned.The root cause of this failure is attributed to instrument mishandling and misuse.As part of investigation, the instrument was further evaluated and found additional failures.First, was a broken monopolar conductor wire at the distal end at the proximal clevis and tube extension.No thermal damage was observed.The instrument was subjected to electrical continuity testing and failed.The root cause of a broken monopolar conductor is typically attributed to a component failure.Second, a broken pitch cable was identified at the distal clevis hub.The broken cable segment that contains the crimp was still installed in the clevis.It is noted that pitch cable breakage occurs when tensile load exceeds the ultimate strength of the material.The pitch cable construction is designed to optimize load and fatigue (cycling) characteristics.Variation in customer use conditions, procedure type, patient anatomy, product handling, instrument tip lengths, grip torque and manufacturing tolerances are few variables which can influence pitch cable failures.Third, a broken grip cable was identified at the distal end at the proximal clevis and tube extension location.This failure is indicative of a component failure.Lastly, blade damage was identified.Both blade edges were indented, which prevented the blades from closing.The root cause of blade damages are attributed to instrument mishandling and misuse.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Type of Device: MONOPOLAR CURVED SCISSORS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• MDR Report Key: 11579982
• MDR Text Key: 246219506
• Report Number: 2955842-2021-10321
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112298
• UDI-Public: (01)00886874112298(10)N11200309
• Combination Product (y/n): N
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470179-19
• Device Catalogue Number: 470179
• Device Lot Number: N11200309 0083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Date Manufacturer Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.