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

Model Number BOND-III

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/06/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023, the complainant contacted leica biosystems and the following details were documented: "fas [name] called in the issue.Main robot critical err, run abandoned on ssa 2 able to repeat slides.Hesitant to use the other ssa and no reported issue on the other trays".On (b)(6) 2023, the assigned local leica field applications specialist immunohistochemistry (fas) visited the customer site and recorded the following information: "customer reported staining issues on recent bond iii processing module and requested assistance".The fas noted "the processing module is well-maintained, ph appropriate bulk fluids, and syringe primes appropriately.Pulled run events for the affected slides and found that a main robot critical error had occurred, and the run was abandoned.Requested an fse on site to further evaluate the issue." the leica fas also confirmed that there was no impact to patient diagnosis due to this event.The fas further noted "customer states that 9 slides did not stain/inconsistent staining and somehow covertiles are not placed back on the slides during processing." the fas documented the affected patient slides were derived from one (1) "[name] dab" tissue staining protocol executed on slide staining assembly (ssa) 2, with the start/end time & date documented as "start time 10:03 am on (b)(6) 2023 and finish time 12:11pm"; the affected patient slides were re-stained using the same instrument.On (b)(6) 2023, the assigned leica field service engineer (fse) visited the customer site and recorded the following information: "customer requested service due to a 126 critical robot error.Read through service logs and found the 126 robot error.Also found some 116 cavro errors proceeding that as well.Ran a robot extremity test that passed with no issues.Ran the lls test that passed with no issues.Checked the resistance readings on the insulator block and there were no issues.Found the calibration for the probe to the washer block and for the mixing vials x axis to be off in -x direction.Also, all ssa positions to be off 30-40 steps in -x direction.During the investigation, found that the customer is using the cut corner slides.This causes the slide to dig into the plastic rack and pop the cover tile out of place." the fse "replaced the aspirating probe.Performed the full instrument calibration.Performed successful heater test and another lls test." the fse recommended to the customer to "not to use the cut corner slides." on (b)(6) 2023, leica biosystems melbourne received information from the assigned leica field applications specialist immunohistochemistry that all patient cases involved in this event were diagnosable.

Manufacturer Narrative

Investigation of this complaint found that the instrument functioned as designed during staining of the nine (9) affected patient slides derived from run 47, which started on slide staining assembly (ssa) 2 at 10:03am on (b)(6) 2023 and failed at 11:52am on (b)(6) 2023 in association with generation of error code 126 main robot critical error.The root cause of the reported "main robot critical err, run abandoned on ssa 2" was determined to be the use of cut corner [clipped corner] slides causing misaligned covertiles.Based on the available information in the instrument service logs and onsite findings by the assigned fse, it was observed that ".The customer was using cut corner [clipped corner] slides.This can cause the slide to dig into the plastic rack and pop the cover tile out of place." 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
• Type of Device: AUTOMATED SLIDE STAINER
• Manufacturer (Section D): LEICA BIOSYSTEMS MELBOURNE PTY. LTD; 495 blackburn road; mount waverley, vic 3149 ; AS 3149
• Manufacturer (Section G): LEICA BIOSYSTEMS MELBOURNE PTY. LTD; 495 blackburn road; mount waverley, vic 3149 ; AS 3149
• Manufacturer Contact: daya currie ; 495 blackburn road; mount waverley, vic 3149 ; AS 3149
• MDR Report Key: 17883021
• MDR Text Key: 325250925
• Report Number: 8020030-2023-00029
• Device Sequence Number: 1
• Product Code: KPA
• UDI-Device Identifier: 09349458000004
• UDI-Public: 09349458000004
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BOND-III
• Device Catalogue Number: 21.2201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2023
• 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