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

Model Number 480445-04

Device Problem Use of Device Problem (1670)

Patient Problem Bowel Perforation (2668)

Event Date 09/11/2023

Event Type  Injury  

Event Description

It was reported that during a da vinci-assisted distal gastrectomy procedure, while reconstructing the stomach using the sureform 45 stapler instrument, the wall of the duodenum was perforated with the anvil portion of the instrument.The instrument was never fired; they positioned the anvil to the duodenal side, and then the perforation occurred.The surgeon created a small unplanned abdominal incision to resect about 1 cm of duodenal tissue via laparotomy.This tissue excision was unplanned.No da vinci instruments were used to resect the duodenum through this incision, and it was not resected laparoscopically.There was no unexpected bleeding as a result of this issue.No malfunctions of a da vinci system, instrument, and/or accessory occurred.The procedure was reportedly completed by re-docking the system and repairing the perforation with a 3rd party stapler.The patient did not experience any postoperative complications as a result of this issue.They were discharged from the hospital, and the surgeon does not have any concerns regarding long-term complications for this patient.

Manufacturer Narrative

Based on the current information provided, the cause of the intraoperative complication is related to surgical technique.No malfunctions of a da vinci system, instrument, and/or accessory occurred.The product has not been returned to intuitive surgical, inc.(isi) for evaluation.A review of the advanced instrument log for the sureform 45 stapler instrument associated with this event was performed by an isi failure analysis engineer (fae).Per the fae, the logs show the instrument was installed on the system 1 time, and it did not clamp or fire any reloads.On the only install, the system failed to detect the reload color, and the user manually selected the blue reload.There were no errors in the logs during the time this instrument was installed.The instrument was then removed, and it was not used again in the procedure.A review of the site's system logs was conducted by an isi regulatory post-market surveillance (rpms) analyst.Per the investigation, no related system errors occurred during the surgical procedure that would have likely caused or contributed to the reported complaint.

• Brand Name: SUREFORM
• Type of Device: SUREFORM 45
• 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: 18010858
• MDR Text Key: 326608428
• Report Number: 2955842-2023-19633
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10886874117580
• UDI-Public: (01)10886874117580(10)T12221128
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K183224
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 480445-04
• Device Catalogue Number: 480445
• Device Lot Number: T12221128 0232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES