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

Model Number 471405-06

Device Problems Difficult to Remove (1528); Material Split, Cut or Torn (4008)

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

Event Date 10/03/2023

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) did receive the force bipolar instrument to perform failure analysis (fa).Fa was able to confirm/reproduce the customer reported complaint.The instrument was found to have a bent grip, causing vertical misalignment of the grips.There was a portion of the grip, near the base, closest to distal clevis pin that extended further than manufactured.Additional observations not reported by site: the instrument was found to have a dislodged conductor wire at the distal end.The instrument was found to have a segment of the conductor wire sticking out.A loop of wire is sticking out such that the wire protrudes above the outer surface of the main tube.There is also a piece of the conductor wire dislodged where the grips and distal clevis meet.The wire insulation was damaged.The instrument passed the electrical continuity test.No signs of thermal damage were observed.The instrument was found to have damaged conductor wire insulation at the distal end.There was no thermal damage and no missing material, but the wires were exposed.The instrument was found to have a frayed grip cable at the distal end.

Event Description

It was reported that during a da vinci-assisted malignant hysterectomy surgical procedure, the force bipolar (fb) jaws were stuck in the cannula because of the ¿fixed tip¿.The fb instrument and cannula were removed together.The customer used a backup fb instrument to continue with the procedure.The procedure was completing as planned with no reported injury.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the force bipolar (fb) instrument was inspected prior to use with no issue.The customer had to remove the fb instrument together with the cannula because it could not be removed through the cannula.There was no port incision enlargement.There was no fragment falling into patient.There was no dislodged/misaligned jaw or grip tip sticking out the fb instrument.

• 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: 18044670
• MDR Text Key: 327030992
• Report Number: 2955842-2023-19809
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874120767
• UDI-Public: (01)00886874120767(10)K10211122
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K214095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/06/2023

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: 471405-06
• Device Catalogue Number: 471405
• Device Lot Number: K10211122 0185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/06/2023
• Initial Date FDA Received: 10/31/2023
• Supplement Dates Manufacturer Received: 11/01/2023
• Supplement Dates FDA Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2021
• 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 Sex: Female