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 06/29/2023

Event Type  malfunction  

Manufacturer Narrative

An investigation is in progress to determine the cause of this reported event.Isi has received the force bipolar instrument involved with this complaint; however, failure analysis has not completed their investigation.Additional information is being gathered to determine the contribution of the device to the customer reported issue.A follow-up mdr will be submitted after failure analysis investigation and if additional information is obtained.

Event Description

It was reported that during a da vinci-assisted ventral hernia tapp surgical procedure, the customer found it difficult to remove the force bipolar instrument from the 8mm cannula.A piece of the metal on the instrument wrist would not come out of the cannula.The whole cannula had to be undocked and removed with the instrument still inside.No pieces broke off from the instrument.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) has attempted to obtain additional information related to the reported event.However, as of the date of this report, no additional information has been provided.

Manufacturer Narrative

Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The force bipolar instrument was analyzed, and the reported failure was replicated and confirmed.Failure analysis found the primary failure of the instrument grips-tips cracked to be related to the customer-reported complaint.The instrument was found to have a cracked grip at the midpoint of the grip hinge.There was no material found missing.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The instrument grip became stuck in the cannula upon removal from the system on 1 of 3 attempts.The grip became stuck where the cracking damage was located.The complaint was confirmed based on 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: 17950263
• MDR Text Key: 325857329
• Report Number: 2955842-2023-19279
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874120767
• UDI-Public: (01)00886874120767(10)K15230226
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/18/2023

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: K15230226 0241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2023
• Initial Date FDA Received: 10/17/2023
• Supplement Dates Manufacturer Received: 10/20/2023
• Supplement Dates FDA Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2023
• 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