MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. THUNDERBEAT 5 MM, 35 CM, PISTOL GRIP; ULTRASONIC SURGICAL DEVICE

Model Number TB-0535PC

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Patient Involvement (2645)

Event Date 12/28/2020

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.It is reported that the user mishandled the device leading to the minor injury that occurred.No medical or surgical intervention was required.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported while preparing a thunderbeat for use, the user was accidentally cut by the device.The user mishandled the device, and the device poked through packaging, accidentally cutting the user's hand.The cut was treated by applying surgical glue to dress the wound.No additional consequences to the user occurred.There was no malfunction of the device.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the probable cause is likely user mishandling.This issue is addressed in the instructions for use (ifu): "open the sterile pack and carefully take out the packaging spacer and the thunderbeat instrument from the sterile pack using good sterile technique and check the appearance of the instrument, especially confirming the following: ¿ the shaft is not torn, cut, peeled, or rolled up.¿ the metallic section on the shaft and the grasping section is not corroded or discolored.¿ the appearance is free of bending, deformation, and other irregularity.In addition, if the packaging spacer is enclosed in the sterile pack, carefully takeout it from the sterile pack using good sterile technique.Should any damage and/or irregularity be observed, do not use the thunderbeat instrument and replace it with a new thunderbeat instrument.".

• Brand Name: THUNDERBEAT 5 MM, 35 CM, PISTOL GRIP
• Type of Device: ULTRASONIC SURGICAL DEVICE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11091205
• MDR Text Key: 224579161
• Report Number: 8010047-2020-11090
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170308659
• UDI-Public: 04953170308659
• Combination Product (y/n): N
• PMA/PMN Number: K132703
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TB-0535PC
• Device Lot Number: 9XK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1