MAUDE Adverse Event Report: OLYMPUS THUNDERBEAT HAND PIECE; THUNDER BEAT

Lot Number 47K

Device Problems Component Missing (2306); Device Or Device Fragments Location Unknown (2590); Device Operates Differently Than Expected (2913)

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

Event Date 07/23/2015

Event Type  malfunction  

Event Description

During laparoscopic portion of the procedure.Thunderbeat hand piece malfunctioned, second hand piece opened, second thunderbeat malfunctioned as well, after inspecting second device half of small plastic piece was noted to be missing.Doctor was notified, surgical field and surrounding area were searched by all the team members, inside of pt's abdomen was inspected with laparoscopic by surgeon, missing piece of thunderbeat was not located.

• Brand Name: THUNDERBEAT HAND PIECE
• Type of Device: THUNDER BEAT
• Manufacturer (Section D): OLYMPUS
• MDR Report Key: 4964721
• MDR Text Key: 19029196
• Report Number: MW5045034
• Device Sequence Number: 2
• Product Code: GEI
• 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: 07/29/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2016
• Device Lot Number: 47K
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 43 YR