MAUDE Adverse Event Report: ECOLAB INTRAOPERATRIVE PROBE COVER

Model Number	PC1290
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Two probe cover were used and unclear which may have caused the event (pc1289 and pc 1290).
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: 8662787
• Report Number: 8043817-2019-40021
• Device Sequence Number: 381057
• Product Code: KKX
• UDI-Device Identifier: 50748426047869
• UDI-Public: 50748426047869
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K882724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2019

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 Expiration Date: 12/27/2023
• Device Model Number: PC1290
• Device Lot Number: D190229
• 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: 06/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention