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

Model Number 471405-06

Device Problems Difficult to Remove (1528); Device Dislodged or Dislocated (2923)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 08/23/2023

Event Type  Injury  

Manufacturer Narrative

An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) received the force bipolar instrument involved with this complaint and completed the device evaluation.Failure analysis investigations did not replicate nor confirm 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 grips opened and closed properly.The instrument was installed and removed without any issues on multiple attempts.The instrument was fully functional.There was an additional observation not reported by the site and not related to the reported issue.The instrument was found to have damage to the conductor wire insulation in the grip routing.Visual inspection found the internal wire to not be exposed.The instrument grips were manually manipulated, and the instrument passed the electrical continuity test on all three attempts.There were no signs of thermal damage.Images of the force bipolar instrument related to this event were received and reviewed.From the images provided, the grip tang (grip base) is dislodged from the distal clevis.

Event Description

It was reported that during a da vinci-assisted benign hysterectomy surgical procedure, the force bipolar instrument was broken and stuck in the cannula.There was no report of any fragments falling inside the patient.The procedure was completed.Intuitive surgical, inc.(isi) performed follow-up and obtained the following additional/updated information regarding the reported event: it was confirmed that the correct product was returned to isi for evaluation.No instrument collision was observed during the procedure.The base of the instrument's wrist was damaged, and the jaws were stuck in a closed position.As a result, the port incision was increased by the surgeon to remove the instrument and cannula together.The instrument's jaws were not stuck on tissue at the time of the event.There was no missing part/material observed from the instrument.It was confirmed that no fragments fell inside the patient during the procedure.

• Brand Name: ENDOWRIST
• Type of Device: FORCE BIPOLAR
• 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: 17839751
• MDR Text Key: 324533079
• Report Number: 2955842-2023-18819
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874120767
• UDI-Public: (01)00886874120767(10)K10230310
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K214095
• 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: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471405-06
• Device Catalogue Number: 471405
• Device Lot Number: K10230310 0136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2023
• Initial Date Manufacturer Received: 09/01/2023
• Initial Date FDA Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2023
• 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: 49 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian