MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. SUREFORM 60; STAPLE, IMPLANTABLE

Model Number 480460

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 09/08/2022

Event Type  malfunction  

Event Description

Sureform 60 stapler not working properly; "engagement issue." ref: 48060, lot: l10220809 no patient harm.Fda safety report id# (b)(4).

• Brand Name: SUREFORM 60
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; sunnyvale CA 94086
• MDR Report Key: 15418677
• MDR Text Key: 299955036
• Report Number: MW5112012
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 480460
• Device Lot Number: L10220809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2022
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1