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

Model Number 471093-11

Device Problem Difficult to Remove (1528)

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

Event Date 09/22/2023

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted surgical procedure, a customer stated a recoverable fault was generated on arm 4 indicating unexpected movement.The customer proceeded to remove the instrument from the arm and recover the fault to continue the surgery, but this same fault occurred a second time.The instrument was removed again and arm4 was repositioned but minutes later, when the surgeon already had the tissue attached with the prograps forceps instrument on arm 4, it generated a recoverable fault 23072 that was not possible to recover.After several attempts to recover the failure from the vision cart, the robot was restarted but the failure persisted.A third attempt was made with a hard reset to try to recover the failure without success.Because the prograsp forceps was holding tissue and the failure only allowed to deactivate the arm to continue the surgery by the robot, they proceeded to use the release kit in the prograsp forceps to release the tissue and remove the instrument, after deactivating the arm, the surgeon decided to continue the procedure only with three arms.The procedure was completed with no reported injury.Intuitive surgical inc.(isi) followed up with the customer to confirm that the system booted up with no issues and the issue occurred during the procedure.The customer was able to remove the instrument from the arm and recover the fault to continue the surgery, but this same fault occurred a second time.The instrument was removed again and arm4 was repositioned but minutes later, when the surgeon already had the tissue attached with the prograp forceps instrument on arm 4, it generated a recoverable fault 23072 that was not possible to recover.After several attempts to recover the failure from the vision cart, the robot was restarted but the failure persisted.A third attempt was made with a hard reset to try to recover the failure without success.Because the prograsp forceps was holding tissue and the failure only allowed to deactivate the arm to continue the surgery.The procedure was completed robotically with 3 arms with no patient impact or harm.

Manufacturer Narrative

An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The prograsp forceps was analyzed, and the complaint was not confirmed by failure analysis.Failure analysis investigations not replicated nor confirmed the customer reported complaint.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 grip opened and closed properly.Performed bumper test, roll, up and down, left to right articulation on in-house system with no issue.The instrument was fully functional.For clarification, the mentioned 2307 error was pointing to suj4 z-axis pot (dof1) and not the instrument.No engagement error 22020 and recognition 282 errors found in the logs.Additionally, the instrument was found to have a broken grip at the grip base.A piece approximately 0.051" x 0.154" was found to be broken off.The broken piece was not returned.The instrument was found to have various scratch marks with light material removed on the main tube.The scratch marks were 0.096¿ - 0.199 in length and were not aligned with the tube axis.

• Brand Name: ENDOWRIST
• Type of Device: PROGRASP 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: 18036458
• MDR Text Key: 326922868
• Report Number: 2955842-2023-19780
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874119785
• UDI-Public: (01)00886874119785(10)K10230212
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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
• Report Date: 10/11/2023

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: 471093-11
• Device Catalogue Number: 471093
• Device Lot Number: K10230212 0228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2023
• Initial Date Manufacturer Received: 10/11/2023
• Initial Date FDA Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2023
• 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
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 82 KG