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

Model Number 471405-06

Device Problem Difficult to Remove (1528)

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

Event Date 01/19/2024

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has received the instrument for evaluation.However, the failure analysis has not been completed yet.A follow-up mdr will be submitted if additional information is obtained.

Event Description

It was reported that during a da vinci-assisted hysterectomy surgical procedure, the force bipolar instrument was unable to remove from cannula due to part of instrument catching the distal lip of cannula.The cannula removed from patient with instrument intact and pin gauge passed through cannula after removal of instrument.The procedure was completed with no reported injury.

Manufacturer Narrative

Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The force bipolar instrument was analyzed and found to have hairline cracks on grip input disk #7.This caused inability to remove the instrument from cannula.The complaint was confirmed by failure analysis.

Event Description

Refer to h10/h11 for follow-up information.

• 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: 18899360
• MDR Text Key: 337641223
• Report Number: 2955842-2024-12369
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874120767
• UDI-Public: (01)00886874120767(10)K11230302
• 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
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

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: 471405-06
• Device Catalogue Number: 471405
• Device Lot Number: K11230302 0199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2024
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 03/13/2024
• Supplement Dates Manufacturer Received: 05/17/2024
• Supplement Dates FDA Received: 06/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2023
• 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 Sex: Female