MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; TENACULUM FORCEPS

Model Number 470207-10

Device Problems Material Fragmentation (1261); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/12/2024

Event Type  Injury  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has received the tenaculum forceps instrument involved with this complaint to perform failure analysis; however, the evaluation is not yet complete.A follow-up mdr will be submitted once the product is evaluated and/or if additional information is received.The provided images were reviewed by an intuitive surgical, inc.(isi) regulatory post-market surveillance analyst.The images appear to show two instruments with distal damage resulting in an offset from the main shaft.One of the instruments appears to have a cable protruding from the forceps.Failure analysis investigations are underway to further assess the damage and identify the root cause.The report with patient identifier (b)(6) documents the other instrument involved in the event.Blank mdr fields: the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Field e4 is blank because it is unknown if the initial reporter submitted a report to the fda.Fields g5 and g7 are not applicable.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the tenaculum forceps instrument froze while rotating the tenaculum, the customer couldn't remove it from the cannula and had to use the emergency key.The procedure was completed.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: all fragments were retrieved and there were no additional procedures to remove them.The surgeon was able to retrieve the fragment with another instrument and pulled it out of the abdomen.There were no post-operative tests to check for remaining fragments.The case was finished robotically, and the instrumentation was switched out.The instrument was not removed prior to the breakage and the tenaculum stayed in the patient until it malfunctioned.The site experienced some resistance when removing the instrument from the cannula.It was required to break it out.There was no incision increase needed as the arm and cannula came out easily.The fragment came out as a small piece of fiber and was discarded by the customer before the instrument was being sent out.The second broken arm had no splintering of material.

Manufacturer Narrative

The tenaculum forceps instrument has been returned and evaluated by the failure analysis team.The instrument was found to have a broken main tube.The whole tip was found to be completely detached from main tube base measuring proximately 0.196¿ x 0.032¿ and it was returned with the instrument.Components adjacent to this broken main tube show damage.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Type of Device: TENACULUM FORCEPS
• 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: 19056604
• MDR Text Key: 339551712
• Report Number: 2955842-2024-13011
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112366
• UDI-Public: (01)00886874112366(11)201203(10)N10201207
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470207-10
• Device Catalogue Number: 470207
• Device Lot Number: N10201207 0057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/06/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/03/2020
• 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: 47 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American