MAUDE Adverse Event Report: ECOLAB INTRAOPERATRIVE PROBE COVER

Model Number	PC1289
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis summary: unopened samples were tested.The nonconformance could not be confirmed because the samples did not leak.In conclusion, the cause of the leak could not be confrimed.
Event or Problem Description
It was further reported that a probe pin hole was suspected.

• Brand Name: INTRAOPERATRIVE PROBE COVER
• Common Device Name: PROBE COVER
• Manufacturer (Section D): ECOLAB; 1 ecolab place; st paul MN 55102
• MDR Report Key: 8749666
• Report Number: 8043817-2019-40026
• Device Sequence Number: 1690304
• Product Code: KKX
• UDI-Device Identifier: 50748426047869
• UDI-Public: 50748426047869
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: PC1289
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1