MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC ENT STRAIGHT SUCTION; INSTRUMENT, STEREOTAXIC

Model Number	9733449
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information provided as no patient was involved in this concern.No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that, while outside of a procedure, the suction was not operating as designed.There was no patient present when this issue was identified.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that the issue was isolated to the seventy degree suction documented in mdr 1723170-2019-04030.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received from a manufacturer representative indicated the 70 degree suction was disposed of by the account.No further information was available.

• Brand Name: ENT STRAIGHT SUCTION
• Common Device Name: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8782348
• Report Number: 1723170-2019-04029
• Device Sequence Number: 1999580
• Product Code: HAW
• UDI-Device Identifier: 00613994378422
• UDI-Public: 00613994378422
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K050438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9733449
• Device Catalogue Number: 9733449
• Device Lot Number: 18062562
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2019
• Supplement Date Received by Manufacturer: 07/16/2019; 08/21/2019
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 08/13/2019; 09/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1