MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM STAPLER 60

Model Number 480460-08

Device Problems Failure to Cut (2587); Failure to Fire (2610)

Patient Problem Internal Organ Perforation (1987)

Event Date 03/31/2020

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the causes of the customer reported failure mode and the patient¿s operative complication are unknown. Isi has requested for the sureform stapler 60 instrument to be returned for evaluation. Isi has also attempted to contact the site to gather additional information regarding the reported event. However, as of the date of this report, no new information has been obtained. If additional information is received, a follow-up mdr will be submitted. Review of the site's system logs is unable to be performed at this time as the procedure date is unconfirmed. No image or video of the reported event were provided for review. This complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that a sureform stapler 60 instrument did not staple and/ or cut, and the patient sustained a perforation of the stomach lining. At this time, the cause of the stomach perforation is unclear and it is unknown what medical intervention, if any, was administered due to the operative complication. Follow-up was attempted, but the patient information was either unknown or unavailable. The expiration date is not applicable. The product is not implantable.

Event Description

It was reported that during an unspecified vinci-assisted surgical procedure, the surgical staff encountered an issue with a sureform 60 instrument. It was alleged that the stapler instrument did not staple and/ or cut. Per the initial reporter, there was a perforation of the stomach lining. The following information is unknown: what surgical task was being performed, whether additional medical/ surgical intervention was or will be administered as a result of this issue, the procedure outcome, and patient's current status.

• Brand Name: SUREFORM
• Type of Device: STAPLER 60
• 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: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 10016320
• MDR Text Key: 196769012
• Report Number: 2955842-2020-10441
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K173721
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 480460-08
• Device Catalogue Number: N/A
• Device Lot Number: L90191014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 04/30/2020 Patient Sequence Number: 1