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

Model Number	BOND-MAX AUTOMATED SLIDE STAINER
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Details of the affected slide staining run(s) and the instrument logs were not available to the manufacturer as the complainant declined to provide this to leica biosystems.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 information available details that ¿the cause of the issue is waiting investigation¿.The root cause for the ¿¿reported errors ¿¿ could not be unequivocally established from the information available.The information available states that ¿after repairing, the instrument returned to normal.¿ the device was not available for evaluation as the complainant site declined to allow leica biosystems engineers to attend to assess the function and operation of the instrument.
Event or Problem Description
On 14 august 2024, the complainant submitted a medical device adverse event report for marketing authorization holders to the (b)(6) documenting the following: ¿abnormalities occur frequently, errors are reported all the time, and a large number of samples and films are wasted.¿ on (b)(6) 2024, leica biosystems melbourne received the following information: ¿we receive an ae from (b)(6) hospital in the (b)(6) ¿product name:fully automated ihc and ish staining system product code/model : bond-max serial number : (b)(6) date of use:2024-7-31 ae number:[report number] case description:on (b)(6) 2024, mulfunction [sic] happened frequently, reported errors, and wasted a lot of samples and films.The issue led to tissue damage.The cause of the issue is waiting investigation.After repairing, the instrument returned to normal.¿ on (b)(6) 2024, the assigned customer service engineer confirmed with the customer that ¿¿some patients had repeated biopsies.The department is managed by a trustee.If there is a problem with the equipment in the department, the equipment department will contact a third party for repair.The customer is unwilling to provide detailed information.We also encountered resistance when asking the customer to cooperate with us to retrieve the log¿an engineer to visit the customer next week for confirmation.Specific information and logs will be supplemented later.¿ on 23 august 2024, leica biosystems melbourne received additional information from the local leica qa specialist from the local qara team regarding the circumstances of the event: "the tissue is damaged.Some slices are small specimens, such as puncture tissue, which may not be cut out again¿the hospital equipment department has repaired it¿the machine is running normally now.¿ on (b)(6) 2024, leica biosystems melbourne was advised no further information regarding the affected patients or the circumstances of the event was available.

• Brand Name: BOND-MAX 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: 20131858
• Report Number: 8020030-2024-00030
• Device Sequence Number: 20638300
• Product Code: KPA
• UDI-Device Identifier: 09349458000011
• UDI-Public: (01)09349458000011(11)161206
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/04/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: BOND-MAX AUTOMATED SLIDE STAINER
• Device Catalogue Number: 49.0051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2016
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown