MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; STAPLER 30

Model Number	470430-08
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted total colectomy surgical procedure, the stapler 30 instrument blade did not close and the tissue could not be cut off because it did not move during use.Though it was usable in the first and second time, the blade of the third winding did not close, and even if the tip was checked, it was not damaged, and the replacement blade was removed without resistance.The procedure was completed as planned with no reported injury.Intuitive surgical, inc.(isi) followed up with the surgeon and obtained the following additional information: the first fire worked.The target tissue at the time of anastomosis between the ileum and the anus when advanced 1 cm.When performing an anastomosis between the ileum and the anus, it stopped halfway when it had advanced 1 cm.It displayed a message of "blade may be exposed." a new stapler instrument was taken out and completed the fire with a green reload.The event involved a failure to fire and partial fire.The event did not involve tissue being pushed forward/dragged during the firing process.There were malformed or unformed staples.The reload had an exposed blade.There were no staples missing from the staple line.There were no holes/gaps observed within the staple line.There was no bleeding observed on the staple line due to the stapler issue.The second fire was involved with the reported event.There was no unplanned tissue removal due to the firing failure.The issue was resolved with a backup stapler instrument.The reload that was used with the stapler 30 instrument would not be returned.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis and the complaint was confirmed.The stapler 30 instrument was analyzed and found to have two firing failures based on a log review which was not replicated through in-house testing.The instrument was installed onto an in-house system and fired on a test sheet using an in-house grey reload and an in-house green reload.The instrument fired successfully, and the resultant staple-line was visually inspected.The cutline appeared smooth and consistent, with no jagged edges or tearing observed.All staples were deployed and correctly formed into the proper b-shape.

• Brand Name: ENDOWRIST
• Common Device Name: STAPLER 30
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 20920698
• Report Number: 2955842-2024-23161
• Device Sequence Number: 5293998
• Product Code: NAY
• UDI-Device Identifier: 00886874112700
• UDI-Public: (01)00886874112700(10)T10200604
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K152421
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/19/2024

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
• Operator of Device: Health Professional
• Device Model Number: 470430-08
• Device Catalogue Number: 470430
• Device Lot Number: T10200604 0025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES.
• Patient Sex: Prefer Not To Disclose