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 Device Interaction Problem (4001)

Patient Problem Laceration(s) (1946)

Event Date 03/23/2021

Event Type  Injury  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has received the force bipolar (fb) instrument associated with this complaint and completed investigations.Failure analysis (fa) investigation did not confirm nor replicate the customer reported complaint, "jaws broke off." visual inspection of the instrument found no physical nor cosmetic damage on the distal end or the back end.No pieces were missing, and the jaws were still installed with no damage.An electrical continuity test was performed and the instrument passed.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 and passed the grip management test.The instrument was fully functional.There was no problem detected.

Event Description

It was reported that during a da vinci-assisted hysterectomy surgical procedure, a force bipolar (fb) instrument broke inside the patient as the surgeon was grasping unspecified tissue.The system logs showed 'erbe errors on arm 2.' it was noted that the pulley system cabling of the instrument completely broke on the backside into the shaft, and there was a hook around the pulley.It was reported that, the hook on the crossbar caught on the trocar when the customer tried to remove the instrument from the system's arm.A fenestrated bipolar forceps (fbf) instrument was used to try and close the fb instrument but they could not get the fb instrument out.The staff, put in a pion into the trocar (described as a double sided smooth retractor) and went to de-cannulate the instrument and the cannula together, in order to remove the instrument.However; in the process, the hook-part of the instrument nicked and cut the patient at the cannula site.There was little-to-no visual bleeding.As a precaution, the surgeon placed one (1) extra suture at the port-site, during the port-site closure.There were no visually observed fragments falling into the patient throughout the procedure and an x-ray was obtained at the time of the event, and the results found no evidence of a fragment in the patient.The customer re-installed a cannula in the system's arm 2 and completed the procedure robotically.The procedure was completed with no report of patient harm, injury, or adverse outcome.

• 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: 17093949
• MDR Text Key: 316850883
• Report Number: 2955842-2023-16122
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874120767
• UDI-Public: (01)00886874120767(10)N12201007
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K214095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/23/2021

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: N12201007 0092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Initial Date Manufacturer Received: 03/23/2021
• Initial Date FDA Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2020
• 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: 41 YR
• Patient Sex: Female