MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 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	09/30/2020
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: 9 events were reported for this quarter.Product return status: 5 devices were received.4 device investigation types have not yet been determined.Event confirmation status: 5 reported events were confirmed.Evaluation results: 4 devices were found to be affected by faulty irrigation/pinch valve.1 device was found to be affected by a faulty irrigation/pinch valve and damaged power supply board (psb).Additional information: 9 devices were not labeled for single-use.9 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 9 malfunction events in which the device experienced an irrigation issue that could lead to overheating.9 events had no 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: 9 previously reported events are included in this follow-up record.Product return status: 7 devices were received.2 devices were not available for evaluation.
Event or Problem Description
This report summarizes 9 malfunction events in which the device experienced an irrigation issue that could lead to overheating.9 events had no 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 INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• MDR Report Key: 10748008
• Report Number: 0008043928-2020-00015
• Device Sequence Number: 17153512
• 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: 9
• 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): 04/30/2021

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: No Information
• Device Model Number: 5450850000
• Device Catalogue Number: 5450850000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1