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 02/20/2024

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted inguinal hernia - bilateral surgical procedure, the force bipolar instrument was used for a surgical task and the joint that allows the end of the tool to rotate was grabbing tissue and getting stuck.Use of the instrument was discontinued, and it was replaced to the backup.The user completed the procedure using the same system.No known impact or patient consequence was reported.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: fatty tissue was adhered to the instrument.The surgeon was dissecting the hernia at the time of the event.The instrument was in use a few minutes prior to the reported event.The tissue was getting caught in the wrist where the head of the instrument rotates.The surgeon released the tissue with another instrument.No tissue was excised due to this event.There was no bleeding due to the event.The patient did not experience any post-operative complications.

Manufacturer Narrative

Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The force bipolar instrument was analyzed.The instrument was found to have one bent grip, causing misalignment of the grips.There was a 0.0190¿ offset at the tips.The grips do not show cracking damage.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.

• 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: 18919677
• MDR Text Key: 337845945
• Report Number: 2955842-2024-12077
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874120767
• UDI-Public: (01)00886874120767(10)K14230302
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/20/2024

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: K14230302 0093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/18/2024
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Race: White