MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH INTEGO PRO CS; UNIT, OPERATIVE DENTAL

Catalog Number	6591866
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such.This event, therefore, is reportable per 21 cfr part 803.It has been noted that the customer refuses to work with an authorized dealer but has hired an unauthorized service provider.Photographic evidence suggests that blood is not being evacuated properly.Root causes to be determined.A dentsply sirona technician is being dispatched to assist with device evaluation.
Event or Problem Description
The customer alleged that blood came from the cup filler into the patient's drinking cup.The patient, user or third-party were not injured.The patient did not drink from the drinking cup.If the treatment center is assembled and maintained correctly, it is technically impossible that blood can enter the water-way of the cup water.There is an on-going onsite investigation of this device.

• Brand Name: INTEGO PRO CS
• Common Device Name: UNIT, OPERATIVE DENTAL
• Manufacturer (Section D): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, hessen D-646 25; GM D-64625
• Manufacturer (Section G): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, hessen D-646 25; GM D-64625
• Manufacturer Contact: dan eagar ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494593
• MDR Report Key: 21179758
• Report Number: 9614977-2024-00032
• Device Sequence Number: 8630738
• Product Code: EIA
• UDI-Device Identifier: E27665918660
• UDI-Public: E27665918660
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K150909
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/17/2025

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 Catalogue Number: 6591866
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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