MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) MALLEABLE SUCTION MEDIUM, BALL TIP; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

Catalog Number	9735018
Medical Device Problem Codes	Communication or Transmission Problem (2896); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information not provided due to japanese patient privacy regulations.The suspect instrument has been received by the manufacturer for evaluation.When the instrument was connected to a known good system, the malleable suction was recognized and tracked without issue.No fault found.
Event or Problem Description
A site representative reported that during pituitary lumpectomy, the malleable suction had recognition failure.The procedure was completed with the use of back up instrument.There was no delay to procedure.No impact on patient outcome.
Additional Manufacturer Narrative
Device code was corrected.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MALLEABLE SUCTION MEDIUM, BALL TIP
• Common Device Name: EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7222045
• Report Number: 1723170-2018-00398
• Device Sequence Number: 1367880
• Product Code: PGW
• UDI-Device Identifier: 00643169443532
• UDI-Public: 00643169443532
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2019

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: Physician
• Device Catalogue Number: 9735018
• Device Lot Number: 161013D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2018
• Supplement Date Received by Manufacturer: 01/05/2018
• Initial Report FDA Received Date: 01/26/2018
• Supplement Report FDA Received Date: 05/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1