MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SONOPET IQ UNIVERSAL ANGLED HANDPIECE; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	5500255000
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Codes	Burn(s) (1757); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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: 12 events were reported for this quarter.Product return status: 8 devices were received.4 devices had investigation types that have not yet been determined.Evaluation findings (results/components): 2 devices: no device problem found, electrical/electronic component problem identified / transducer.4 devices: results pending completion of investigation / part/component/sub-assembly term not applicable.6 devices: no device problem found / part/component/sub-assembly term not applicable.Product disposition: 3 devices: scrapped by stryker, 4 devices: serviced and returned to customer, 1 device: serviced and put back into stryker stock, 4 devices: product disposition is not yet determined.Additional information: 12 devices were not labeled for single-use.12 devices were not reprocessed or reused.
Event or Problem Description
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Events occurred between july 1 ¿ september 30 2025.This report summarizes 12 events for the failure: overheating of device.1 event had insufficient information.5 events had no health consequences or impact.2 events had minor injury/illness/impairment.4 events had problem identified before clinical use/exposure; there was no patient involvement.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Mfr report # 3015967359-2025-99435.Supplemental rationale: corrected data: b5, h6, h11.12 previously reported events were included in this follow-up record.Product return status: 9 devices were received.1 device was not available for evaluation.2 devices had investigation types that have not yet been determined.Evaluation findings (results/components): 2 devices: no device problem found, electrical/electronic component problem identified / transducer.1 device: no findings available / part/component/sub-assembly term not applicable.7 devices: no device problem found / part/component/sub-assembly term not applicable.2 devices: results pending completion of investigation / part/component/sub-assembly term not applicable.Product disposition: 4 devices: scrapped by stryker.1 device: product not received.4 devices: serviced and returned to customer.1 device: serviced and put back into stryker stock.2 devices: product disposition is not yet determined.
Event or Problem Description
No change.
Event or Problem Description
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Events occurred between july 1 ¿ september 30 2025.This report summarizes 11 events for the failure: overheating of device.- 1 event had insufficient information.- 4 events had no health consequences or impact.- 2 events had minor injury/illness/impairment.- 4 events had problem identified before clinical use/exposure; there was no patient involvement.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Mfr report # 3015967359-2025-99435.Supplemental rationale: corrected data: b5, h1, h6, h11.12 events were previously reported during the reporting quarter; however, - 1 event was reported in error.- 11 previously reported events are included in this follow-up record.Product return status: 10 devices were received.1 device was not available for evaluation.Evaluation findings (results/components): 3 devices: no device problem found, electrical/electronic component problem identified / transducer.1 device: no findings available / part/component/sub-assembly term not applicable.7 devices: no device problem found / part/component/sub-assembly term not applicable.Product disposition: 5 devices: scrapped by stryker.1 device: product not received.4 devices: serviced and returned to customer.1 device: serviced and put back into stryker stock.

• Brand Name: SONOPET IQ UNIVERSAL ANGLED HANDPIECE
• 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-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 23399783
• Report Number: 3015967359-2025-99435
• Device Sequence Number: 15964232
• Product Code: LFL
• UDI-Device Identifier: 07613327298611
• UDI-Public: 07613327298611
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 11
• 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): 04/24/2026

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: 5500255000
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/30/2025
• Supplement Date Received by Manufacturer: 09/30/2025; 09/30/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 01/27/2026; 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown