MAUDE Adverse Event Report: STRYKER MEDTECH SONOPET 110V CONSOLE WITH FOOT PEDAL AND POLE; INSTRUMENT, ULTRASONIC SURGICAL

Model Number	5450850000
Medical Device Problem Code	Inability to Irrigate (1337)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2021
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes 6 malfunction events in which the device experienced an irrigation issue that could lead to overheating.4 events had no patient involvement; no patient impact.2 events 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.Reported events, 6 events were reported for this quarter.Product return status, 5 devices were received.1 device investigation type has not yet been determined.Additional information, 6 devices were not labeled for single-use.6 devices were not reprocessed or reused.
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: h10.6 previously reported events are included in this follow-up record.Product return status: 6 devices were received.
Event or Problem Description
This report summarizes 6 malfunction events in which the device experienced an irrigation issue that could lead to overheating.- 4 events had no patient involvement; no patient impact.- 2 events had patient involvement; no patient impact.

• Brand Name: SONOPET 110V CONSOLE WITH FOOT PEDAL AND POLE
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER MEDTECH; 1131-1 higashi naganuma; inagi MI 206-0 802; JA 206-0802
• Manufacturer (Section G): STRYKER MEDTECH; 1131-1 higashi naganuma; inagi MI 206-0 802; JA 206-0802
• Manufacturer Contact: zach baker ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 13293737
• Report Number: 0008043928-2022-00005
• Device Sequence Number: 14589549
• Product Code: LFL
• UDI-Device Identifier: 07613327291872
• UDI-Public: 07613327291872
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 6
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2022

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 Model Number: 5450850000
• Device Catalogue Number: 5450850000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/31/2021
• Supplement Date Received by Manufacturer: 12/31/2021
• Initial Report FDA Received Date: 01/19/2022
• Supplement Report FDA Received Date: 04/11/2022
• 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