MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; FENESTRATED BIPOLAR FORCEPS

Model Number 471205-17

Device Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

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

Event Date 02/06/2024

Event Type  Injury  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has not received the instrument for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the fenestrated bipolar forceps instrument broke to such an extent that it could not be removed through the reducer.The instrument was removed from the cannula together with it.The instrument was replaced on a backup one with a reducer as well.The procedure continued as planned with no reported injury.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received a da vinci product to perform failure analysis evaluation.The fenestrated bipolar forceps instrument was analyzed and failure analysis investigations confirmed and replicated the customer-reported complaint.The instrument was found to have a broken main tube at the distal tip.No material was found missing.Components adjacent to this broken main tube did not show damage.An additional observation that was not reported by the site was that the proximal clevis of the instrument was dislodged.The dislodged proximal clevis was attached to the main tube.Additionally, isi followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use, as usual, after unwrapping from the sterile pack, and there was no damages or anything out of the ordinary noted.The reason the instrument and cannula were removed together was that the wrist could not be straightened due to physical damage (e.G., broken main tube).The doctor did not remember if the port incision was increased to remove the instrument and cannula together.It was confirmed that the incident involved a fragment falling inside the patient's anatomy, which was retrieved during the same procedure.The fragment was retrieved successfully, and it was not necessary to retrieve it during another surgical procedure.There was no collision with any other instrument or tool during the procedure.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Type of Device: FENESTRATED BIPOLAR FORCEPS
• 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: 18927674
• MDR Text Key: 337958037
• Report Number: 2955842-2024-12579
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119808
• UDI-Public: (01)00886874119808(11)230907(10)K12230907
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K214095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/05/2024

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
• Device Operator: Health Professional
• Device Model Number: 471205-17
• Device Catalogue Number: 471205
• Device Lot Number: K12230907 0386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/19/2024
• Supplement Dates Manufacturer Received: 04/05/2024
• Supplement Dates FDA Received: 05/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2023
• 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