MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; SUREFORM 45 RELOAD BLUE

Model Number	48345B-02
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	11/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted gastric bypass (roux-en-y) procedure, while firing a blue sureform 45 reload with a sureform 45 stapler instrument, the customer observed tissue being pushed and not properly stapled or cut.The customer also identified malformed staples.The surgeon was creating the gastric pouch and the stapler had a long pause during clamping.When the staples were deployed, there was a tissue push and malformed staples.No alarms or errors were displayed by the system.The team used a backup sureform 45 stapler with blue reload; however, the same issue occurred with this firing.This led to a tissue tear on the operative site/target area.A third sureform 45 stapler with blue reload was installed and the surgeon was able to proceed with the case.The surgeon had to create another staple line resulting in a smaller gastric pouch.There was some bleeding, the estimated blood loss is unknown.The procedure was completed robotically.
Additional Manufacturer Narrative
The stapler logs for the stapler used in this event and the following info was provided: logs show sureform 45 stapler instrument part number: 480445-04, lot number: k15240913-0094, was used first, and it was installed on the system 2x and fired 2 reloads (1 gray, 1 blue).On install 1, the system failed to detect the reload color and the user manually selected the gray reload via the gemini user panel interface (gupi) on the surgeon side console (ssc) touchpad.On both installs, the first clamp was successful, and the firings were each completed with no pauses or compression.Next, logs show sureform 45 stapler instrument part number: 480445-04, lot number: k15240913-0097, was used next, and it was installed on the system 12x and fired 12 reloads (1 gray, 1 blue, 3 white, 4 blue, 1 white, 1 blue, 1 white, in that order).On installs 1, 2, 4, 5, and 7-12, all clamp attempts were successful, and the firings were each completed with no pauses for compression.On installs 3, and 6, the first clamps were successful, and the firings were each completed with 2 pauses for compression.Next, logs show sureform 45 stapler instrument part number: 480445-04, lot number: k10240405-0669, was installed on the system 1x and fired 1 white reload.On the only install, the first clamp was successful, and the firing was completed with no pauses for compression.

• Brand Name: SUREFORM
• Common Device Name: SUREFORM 45 RELOAD BLUE
• 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: 20845306
• Report Number: 2955842-2024-22513
• Device Sequence Number: 8255954
• Product Code: NAY
• UDI-Device Identifier: 10886874117085
• UDI-Public: (01)10886874117085(10)K11240509
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K183224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification,Other
• Type of Report: Initial
• Report Date (Section B): 11/04/2024

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
• Operator of Device: Health Professional
• Device Model Number: 48345B-02
• Device Catalogue Number: 48345B
• Device Lot Number: K11240509 0526
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: ISIFA2022-02-C
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic