MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. INTUITIVE STAPLER

Lot Number T10180504-007

Device Problems Failure to Calibrate (2440); Defective Device (2588)

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

Event Date 07/11/2018

Event Type  Injury  

Event Description

Pt in surgery for robotic assisted right upper lung wedge resection.During course of surgery, robotic staplers were used.Staplers would not calibrate and failed.Emergency customer service for intuitive surgical inc called.Staplers removed from service and sent to central sterile for inspection.Central sterile to return to the mfr.Surgery continued with laparoscopic staplers being used by the surgeon.No harm to the pt.

• Brand Name: INTUITIVE STAPLER
• Type of Device: STAPLER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.
• MDR Report Key: 7689279
• MDR Text Key: 114177572
• Report Number: MW5078384
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: T10180504-007
• 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 Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 80