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 instrument for evaluation.However, the failure analysis has not been completed yet.A follow-up mdr will be submitted if additional information is obtained.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.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the tenaculum forceps instrument froze while rotating, could not be removed from the cannula, and the customer 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.Surgeon was able to retrieve the fragment with another instrument and pulled 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 as it was required to break it out.There was no incision increase needed as the arm and cannula came out easy.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

Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The tenaculum forceps instrument was analyzed and reported failure was confirmed.The instrument was found to have a broken main tube approximately.10" from the distal tip.A piece measuring proximately 0.238¿ x 0.275¿ was not returned with the instrument.Components adjacent to this broken main tube showed damage which may indicate potential mishandling.There were scratch marks/abrasions at the distal end of the main tube.Additionally, the instrument was found to have a broken grip cable at the proximal clevis hole.The cable was fully broken.There was no evidence of discoloration or corrosion/contamination on the cables to indicate a reprocessing induced issue.The components surrounding the broken cable did not exhibit abnormal sharp edges or damage that would have contributed to the cable breaking.The instrument was found to have a broken distal pitch cable at the proximal clevis hole.The broken cable segment that contains the crimp was still installed in the clevis.The cable was fully broken.There was no evidence of discoloration or corrosion/contamination on the cables to indicate a reprocessing induced issue.The components surrounding the broken cable did not exhibit abnormal sharp edges or damage that would have contributed to the cable breaking.

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: 19056600
• MDR Text Key: 339553115
• Report Number: 2955842-2024-13045
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112366
• UDI-Public: (01)00886874112366(11)210204(10)N10210208
• 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,Followup
• 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: N10210208 0080
• 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
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2021
• 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