MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. SUREFORM 60 STAPLER; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Lot Number T10190124

Device Problem Firing Problem (4011)

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

Event Date 06/25/2019

Event Type  malfunction  

Event Description

Fired linear robotic stapler, surgeon noted several staples in abdomen not attached to any tissue.Appears stapler did not fire correctly.Fda safety report id# (b)(4).

• Brand Name: SUREFORM 60 STAPLER
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC. ; sunnyvale CA 94086
• MDR Report Key: 8758183
• MDR Text Key: 150144004
• Report Number: MW5087801
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Lot Number: T10190124
• 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: 69 YR