MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 12CM IQ STANDARD; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	550025S307
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events 2 events were reported for this quarter.Product return status 2 device investigation types have not yet been determined.Additional information 2 devices were labeled for single-use.2 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 2 malfunction events in which the device reportedly overheated.2 events had patient involvement; no patient impact.
Event or Problem Description
This report summarizes 1 malfunction event in which the device reportedly overheated.- 1 event had patient involvement; no patient impact.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: b5, h1, h6, h11.2 events were previously reported during the reporting period; however, - 1 previously reported event in this report should have been included under mfr report # 3015967359-2025-01316.- 1 previously reported event is included in this follow-up record.Product return status 1 device was received.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: h6, h11 2 previously reported events are included in this follow-up record.Product return status 1 device was received.1 device investigation type has not yet been determined.
Event or Problem Description
This report summarizes 2 malfunction events in which the device reportedly overheated.- 2 events had patient involvement; no patient impact.

• Brand Name: 12CM IQ STANDARD
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 21878623
• Report Number: 3015967359-2025-00921
• Device Sequence Number: 15367100
• Product Code: LFL
• UDI-Device Identifier: 07613327422467
• UDI-Public: 07613327422467
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2025

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
• Device Catalogue Number: 550025S307
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: 03/31/2025; 03/31/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 07/28/2025; 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown