MAUDE Adverse Event Report: MEDTRONIC XOMED INC. IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) I

Model Number	1898200T
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that surgeon said the handpiece felt hot during use, unknown if blades were hot. when procedure finished surgeon was cleaning up patients nose and noticed a burn at the left nare. the procedure was completed with the reported product.
Additional Manufacturer Narrative
H3: product analysis could not verify excessive heat.Seals and bearings and were corroded.Performed pre-temperature test and after 1 min temperature were gear 79.0, motor 78 and bearing were 78 f.H6: previous codes b17, c20 and d16 are no longer applicable.Additional information received (performed pre-temperature test and after 1 min temperature were gear 79.0, motor 78 and bearing were 78 f which were less than 118f i.E.Meeting no reportability criteria) shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event does not meet the reporting requirements in 21 cfr 803.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information received and indicated that the burn skin was looked like reddened broken skin.Gauze bandage under nose was used to address the burn.Additional information received from medtronic service and repair indicated that performed pre-temperature test and after 1 min temp erature were gear 79.0, motor 78 and bearing were 78 f.

• Brand Name: IPC® HANDPIECE - XPS® STRAIGHTSHOT® M4
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) I
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: justin ellis ; 6743 southpoint drive north; jacksonville, FL 32216 ; 7635265677
• MDR Report Key: 23637821
• Report Number: 1045254-2025-02624
• Device Sequence Number: 15970624
• Product Code: ERL
• UDI-Device Identifier: 00885074080932
• UDI-Public: (01)00885074080932(11)120430
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K041523
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

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: 1898200T
• Device Catalogue Number: 1898200T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 91 KG