MAUDE Adverse Event Report: OLYMPUS CORPORATION OF THE AMERICAS HEADQUARTERS THUNDERBEAT

Device Problems Thermal Decomposition of Device (1071); Malposition of Device (2616); Device Operational Issue (2914)

Patient Problems Bowel Burn (1756); Burn, Thermal (2530); Bowel Perforation (2668)

Event Date 02/15/2018

Event Type  Injury  

Event Description

Pt with bowel perforation post bilateral salpingo-oophorectomy. Possible thermal burn to colon from thunderbeat robotic assistance device. Disposable tip.

• Brand Name: THUNDERBEAT
• Type of Device: THUNDERBEAT
• Manufacturer (Section D): OLYMPUS CORPORATION OF THE AMERICAS HEADQUARTERS; 3500 corporate pkwy; center valley PA 18034 0610
• MDR Report Key: 7323022
• MDR Text Key: 101997131
• Report Number: 7323022
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/28/2018
• Distributor Facility Aware Date: 02/15/2018
• Device Age: NA
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2018

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 03/01/2018 Patient Sequence Number: 1