MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; MEGASUTURECUT ND

Model Number	420309-06
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	12/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Isi has received the mega suturecut needle driver instrument, but analysis has not yet been completed.Therefore, the root cause of the customer reported failure mode could not be determined.A follow-up mdr will be submitted if additional information is received.Based on the information provided, this event is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that the tip from a mega suturecut needle driver instrument broke and fell inside the patient.A backup instrument was used to continue the procedure.All fragments were retrieved and no additional surgical intervention was required.However, unintended fragment(s) falling into the patient may require surgical intervention.At this time, it is unknown what caused the breakage to occur.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the tip of the megasuturecut needle driver instrument broke and fell inside the patient.The customer retrieved the fragment during the same procedure.A backup instrument of the same type was used to complete the procedure with no reported injury.Intuitive surgical, inc.(isi) followed up with the operating room (or) nurse and obtained the following additional information: the tip broke while tying a suture.The customer did not find the tip inside the patient initially, but later the broken tip was found and retrieved.The customer reported the fragment seemed to come with the instrument when the instrument was removed from the patient.All fragments were retrieved and there was no additional surgical procedure required to remove the fragment.The customer did not perform any post-operative tests to check for remaining fragments.The instrument was used for about half an hour prior to the issue.The instrument was inspected prior to use.There was no issue with the functionality of the instrument and the instrument did not collide with any other instruments or other hard material during the surgical procedure.The wrist was straightened upon the final removal of the instrument with no resistance.The customer did not notice any damage to the cannula after the event occurred.The customer did not observe any other damage on the instrument.There was no patient injury and the patient has not returned to the hospital due to experiencing post-surgical complications.No video recording was available for review.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
Additional information can be found in the following sections: g4, g7, h2, h3, h6 and h10.61 - intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis investigation replicated and confirmed the customer reported complaint.The instrument was found to have a broken grip at the grip base.A piece approximately 0.121" x 0.308" was found to be broken off.The broken piece was returned.This failure is most commonly caused by mishandling/misuse, such as excess force applied to the instrument jaws.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: MEGASUTURECUT ND
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 9612932
• Report Number: 2955842-2020-10040
• Device Sequence Number: 19502463
• Product Code: NAY
• UDI-Device Identifier: 00886874111796
• UDI-Public: (01)00886874111796(10)N10180702
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 420309-06
• Device Lot Number: N10180702 580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Initial Date Received by Manufacturer: 12/27/2019
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 01/21/2020
• Supplement Report FDA Received Date: 02/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES