MAUDE Adverse Event Report: MEDTRONIC XOMED INC. IPC® CONSOLE; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Model Number	1898001
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis found that the reported fault could not be duplicated.The console was tested with a test endoscrub footswitch however, the fault could not be duplicated.A second test was performed with the customer's supplied endoscrub footswitch and the reported fault could not be duplicated as well.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A healthcare professional (hcp) reported that the pump for the endoscrub was running on full constantly during a procedure.The staff checked that the pump 1 was plugged in properly however, no result was seen so the pump was turned off.The surgeon had completed most of the functional endoscopic surgery procedure however, due to poor visualization decided to abandon the case.The patient was anesthetized and the procedure was almost finished.There was delay with the procedure.The procedure was abandoned.There was no patient impact or injury.The patient's current status is satisfactory.

• Brand Name: IPC® CONSOLE
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 8317297
• Report Number: 1045254-2019-00068
• Device Sequence Number: 10779653
• Product Code: ERL
• UDI-Device Identifier: 00643169305069
• UDI-Public: 00643169305069
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K081277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/07/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1898001
• Device Catalogue Number: 1898001
• Device Lot Number: 210517084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 02/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENDOSCRUB 2 FOOTSWITCH 1852000 SN:NI LN:NI
• Outcome Attributed to Adverse Event: Other