MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS, INC. BENCHMARK ULTRA; SLIDE STAINER, AUTOMATED

Catalog Number 05342716001

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Head Injury (1879); Headache (1880); Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2022

Event Type  malfunction  

Event Description

A customer in the (b)(6) reported that while working on the benchmark ultra staining module instrument, the left lid counterbalance failed causing the instrument hood to fall on the technician's head.It was reported that the technician visited a general practitioner and was prescribed pain medication and rest.No severe harm/injury to the technician was reported.The issue was resolved locally.The local field service engineer (fse) replaced the lid counterbalance and the instrument functioned as intended.An investigation has been initiated and is ongoing.

Manufacturer Narrative

Investigation is on-going.A follow-up report will be submitted upon the completion of the investigation.(b)(4).

Manufacturer Narrative

An investigation was conducted to evaluate the customer issue.The lid counter balance (hinge) that was returned for investigation was inspected.During the inspection, there were clear indications that the hinge had been stressed passed its mechanical stops when opening the instrument lid.No product problem found.The damage observed on the returned lid counterbalance benchmark ultra svc does not appear to be normal wear and tear.The most likely factor contributing to this issue is an overextension of the hinge caused during the use of the instrument.Added eval method codes: historical data analysis, trend analysis, communication/interviews added patient code: head injury update eval result and conclusion codes to reflect investigation conclusions.

Manufacturer Narrative

Added "discomfort" and "headache" patient codes.Added "hinge" component code.Note that patient code "head injury" and device code "detachment of device or device component" are also displayed in this supplemental mdr for clarity purposes; these codes were already present in the previous mdrs.

• Brand Name: BENCHMARK ULTRA
• Type of Device: SLIDE STAINER, AUTOMATED
• Manufacturer (Section D): VENTANA MEDICAL SYSTEMS, INC.; 1910 e innovation park dr; tucson AZ 85755
• Manufacturer Contact: stacie-ann creighton ; 1910 east innovation park dr; na; tucson, AZ 85755 ; 9082537112
• MDR Report Key: 13483737
• MDR Text Key: 288025332
• Report Number: 2028492-2022-00001
• Device Sequence Number: 1
• Product Code: KPA
• UDI-Device Identifier: 04015630981052
• UDI-Public: 04015630981052
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: 510K 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,Followup,Followup
• Report Date: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05342716001
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1