MAUDE Adverse Event Report: SYSMEX RA CO.,LTD. MAIN PLANT TS-10; AUTOMATED TUBE SORTER

Model Number TS-10

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Laceration(s) (1946)

Event Date 06/19/2023

Event Type  Injury  

Manufacturer Narrative

The user reported that the device generated a lift error.The automated tube sorter ts-10 instructions for use (ifu) chapter 7 - troubleshooting, informs the user: "error message lift probable cause error in mechanical system of carry in line (lift up / lift down position).Actions if there is a foreign object or rack on the carry in line (lift up / lift down position), remove it.Then, touch [ok]." the user is referred to chapter 5 - operation, section 5.7 - removing a rack or foreign object from the carry in line, which provides the following directives: "if there is an unused rack or foreign object on the carry in line, the external indicator light lights red and the alarm sounds until error recovery takes place.Follow the steps below to remove a rack or foreign object from the carry in line." 1 open the side cover.Loosen the knob screw that holds the side cover and open the side cover.The user is warned: "do not touch [ok] when the side cover is open.Risk of injury." 2 check the storage line through the opening.3 insert your hand into the opening and remove the rack or foreign object.4 close the side cover and fasten with the knob screw.5 touch [ok].The error is cleared.Please reference excerpt 1 in the file attachments section of this submission to view the image associated with directive 1, indicating proper access of the side cover.Chapter 2 - safety information, section 2.1 - general information, warns the user of the following: "do not operate this instrument with the right, left or rear covers removed.There is a risk of injury from internal moving parts during operation." chapter 4, part names and functions, section 4.2 - rear and right views, further identifies the area of the side cover to be accessed for rack removal.An associated image depicts and identifies the instrument parts, with the side cover being labeled as follows: "5 - side cover - when a rack must be removed from the carry in line due to an error or otherwise, open this cover to remove the rack." please reference excerpt 2 in the file attachments section of this submission to view the image depicting and identifying the side cover.Please reference excerpt 3 in the file attachments section of this submission to view the image indicating the rear cover that was removed by the user.The investigation found user error caused the event, the user removed the rear cover of the ts-10 with a tool, extending his / her arm inside the device which is a deviation from normal troubleshooting activities described in the ifu.During normal operation, the mechanical arm is not accessible to the user as it is housed in a secured enclosure.Warning statements presented throughout the ifu call attention to important safety and operational information.Non-compliance with this information can compromise the safety features incorporated in the device.

Event Description

The ts-10 had stopped operating due to a rack lift error.The user removed the rear cover of the device to retrieve a jammed rack.Upon reaching into the device, the user was injured by a moving arm.The user sought medical attention and received 3 stitches.

• Brand Name: TS-10
• Type of Device: AUTOMATED TUBE SORTER
• Manufacturer (Section D): SYSMEX RA CO.,LTD. MAIN PLANT; 1850-3 hirooka-nomura; shiojiri, nagano 399-0 702; JA 399-0702
• Manufacturer (Section G): SYSMEX RA CO.,LTD. MAIN PLANT; 1850-3 hirooka-nomura; shiojiri, nagano 399-0 702; JA 399-0702
• Manufacturer Contact: william haste ; 577 aptakisic rd; lincolnshire, IL 60069 ; 2245439459
• MDR Report Key: 17310097
• MDR Text Key: 319006400
• Report Number: 1000515253-2023-00004
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TS-10
• Device Catalogue Number: BN168792
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2023
• Initial Date FDA Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/13/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other