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

Model Number 471405-06

Device Problems Difficult to Remove (1528); Difficult to Open or Close (2921)

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

Event Date 09/20/2023

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted ventral hernia etep surgical procedure, the force bipolar instrument allegedly broke at the wrist and user could not remove it via the cannula.The customer received phone assistance from the technical support engineer (tse).The caller confirmed there were no fragments fallen into the patient when the instrument broke.Tse reviewed the logs and found no related issues.The user removed the cannula and instrument together and replaced the cannula.The user then replaced the instrument with a fenestrated bipolar forceps instrument and no further issue was observed.The tse asked if there was any kink to the jaws before use, caller stated no.The procedure was completed with no reported injury.

Manufacturer Narrative

An investigation was completed to determine the cause of this reported event.Although the complaint was not confirmed by failure analysis since the instrument was not returned, the information gathered 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: 17954708
• MDR Text Key: 325897701
• Report Number: 2955842-2023-19324
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874120767
• UDI-Public: (01)00886874120767(11)230608(10)K10230608(91)0001
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/20/2023

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: K10230608 0205
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/20/2023
• Initial Date FDA Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2023
• 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