MAUDE Adverse Event Report: INTUITIVE SURGICAL SUREFORM 60 STAPLER & BLUE RELOAD; ENDOSCOPE AND ACCESSORIES

Model Number 480460/48360B

Device Problems Retraction Problem (1536); Failure to Form Staple (2579)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/10/2020

Event Type  malfunction  

Event Description

Intuitive surgical, davinci xi sureform 60 stapler delivered a compromised staple line and the blade was also unable to fully retract.Fda safety report id# (b)(4).

• Brand Name: SUREFORM 60 STAPLER & BLUE RELOAD
• Type of Device: ENDOSCOPE AND ACCESSORIES
• Manufacturer (Section D): INTUITIVE SURGICAL ; sunnyvale CA 94086
• MDR Report Key: 9706293
• MDR Text Key: 179417323
• Report Number: MW5092964
• Device Sequence Number: 1
• Product Code: GCP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: 480460/48360B
• Device Catalogue Number: 480460/48360B
• Device Lot Number: L929191202/L91190930
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 29 YR