MAUDE Adverse Event Report: LEICA BIOSYSTEMS MELBOURNE PTY. LTD BOND-III AUTOMATED SLIDE STAINER; SLIDE STAINER, AUTOMATED

Model Number	BOND-III AUTOMATED SLIDE STAINER
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, the complainant contacted leica biosystems with the following details: ¿error 126 and covertile issue error 126 aspiration probe recovered covertile are misaligned during run.Fas [name] is aware of the clipped corners, and is requesting service for error 126¿.On (b)(6) 2024, a local leica technical support engineer documented: ¿.Customer is using clipped corner slides, ( a likely cause of the covertile issue ).¿ on (b)(6) 2024, the assigned leica field service engineer (fse) visited the customer site and recorded the following information: ¿the customer complained of recieving [sic] error 126 software error, xyz_error: action_run_error_xyz_move_fail.Error code 116 occurred once during the run events.Checked all calibration, conducted extremity test , checked z axis home flag and it was not bent.Checked z axis insulator block bracket and loom were not fouling on the robot arm.X axis belt and all connections were secure.¿ the fse ¿verified calibration advised customer to mark slide trays to better identify possible problematic trays.Customer at this time has 4 gen 1 slide trays and 1 gen 3 trays.Conducted calibration verification using gen 3 slide tray without error.No errors were found for error to have occurred.¿ on 13 june 2024, leica biosystems melbourne received confirmation from the assigned leica senior field applications specialist- immunohistochemistry, east that all patient cases were diagnosable and there was no impact on staining.No adverse consequence(s) to a patient(s) has been reported to the manufacturer.
Additional Manufacturer Narrative
Details of the affected tissue processing run(s) were not available to the manufacturer.As a result, it was not possible to assess the operation and function of the instrument.However, based on the information available, the instrument functioned as designed in the circumstances reported by the complainant.The root cause of the reported ¿error 126 and covertile issue¿¿ was determined to be the use of cut corner [clipped corner] slides causing misaligned covertiles.Based on the available information from the leica technical support engineer, it was observed that ¿.Customer is using clipped corner slides, ( a likely cause of the covertile issue ).¿ as a result, the instrument probe most likely collided with the misaligned covertile resulting in the generation of event code 126 - main robot critical error.Leica bond system user manual section 2.6.1 contains the following warnings ¿ ¿use only glass slides of correct size on bond processing modules.Slides of the wrong size may not sit properly in the slide trays, and covertiles will not sit properly on them.Both of these could affect staining quality.¿ and ¿do not use slides with rounded or clipped corners.These slides may fall through the slide tray, and could alter fluid flow under the covertiles, affecting staining quality¿.Although the information available indicates that all patient cases involved in this event were diagnosable, the circumstances involved in this complaint have previously resulted in serious injury.No adverse impact on either the quality of processing of patient tissue samples or to any patient(s) has been reported to the manufacturer in association with the circumstances involved in this complaint.

• Brand Name: BOND-III AUTOMATED SLIDE STAINER
• Common Device Name: SLIDE STAINER, AUTOMATED
• Manufacturer (Section D): LEICA BIOSYSTEMS MELBOURNE PTY. LTD; 495 blackburn road; mount waverley; victoria 00000 0314; AS 0000003149
• Manufacturer (Section G): LEICA BIOSYSTEMS MELBOURNE PTY. LTD; 495 blackburn road; mount waverley; victoria 00000 0314; AS 0000003149
• Manufacturer Contact: daya currie ; 495 blackburn road; mount waverley, vic; AS 0000003149 ; 92117271
• MDR Report Key: 19534399
• Report Number: 8020030-2024-00018
• Device Sequence Number: 8412888
• Product Code: KPA
• UDI-Device Identifier: 09349458000004
• UDI-Public: (01)09349458000004(11)200930
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BOND-III AUTOMATED SLIDE STAINER
• Device Catalogue Number: 21.2201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown