MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; 8MM STAPLER

Model Number	48230B-06
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive the da vinci product with an alleged issue to perform failure analysis.Note: refer to medwatch report (mdr) with mfr.Report #2955842-2025-46429 for mdr submission of the other sureform 30 reload involved with loose staples that fell inside the patient and were retrieved during the same surgical procedure.Additional patient information: bmi = 20.82; height =160cm (5'3").
Event or Problem Description
It was reported that during a da vinci-assisted appendectomy procedure, loose staples from two sureform 30 reloads fell inside the patient.The staples were cleaned up, and no patient injury was reported.The customer opened a third stapler reload and it was normal with no loose staples.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the sureform 30 reload was inspected prior to use and no damage was noted.According to the customer, the sureform 30 stapler instrument did not fire at all.Surgeon did not notice any issues with functionality of stapler reload.All of loose staples were retrieved and confirmed visually.There was no bleeding observed along staple line and there were no holes or gaps within staple line.Procedure was completed robotically with no injury to patient.No additional surgical procedures were required to remove the loose staples.Furthermore, no postoperative tests, such as ultrasound, were performed.Patient has not returned to hospital for any post-surgical complications.

• Brand Name: SUREFORM
• Common Device Name: 8MM STAPLER
• 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: 23708810
• Report Number: 2955842-2025-46430
• Device Sequence Number: 13441924
• Product Code: GDW
• UDI-Device Identifier: 10886874121914
• UDI-Public: (01)10886874121914(10)K10250603
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K211997
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/03/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 48230B-06
• Device Catalogue Number: 48230B
• Device Lot Number: K10250603
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: N/A
• 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: 23 YR
• Patient Sex: Female
• Patient Weight: 53 KG