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 Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	09/30/2019
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: 14 events were reported for this quarter.  product return status: 4 devices were received.10 device investigation types have not yet been determined.  event confirmation status: 4 reported events were confirmed.Evaluation results: 4 devices were found to be affected by a fatigued irrigation/pinch valve.  additional information: 14 devices were not labeled for single-use.14 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 14 malfunction events in which the device experienced an irrigation issue that could lead to overheating.12 events had no patient involvement; no patient impact.2 events had patient involvement; no patient impact.
Event or Problem Description
This report summarizes 15 malfunction events in which the device experienced an irrigation issue that could lead to overheating.13 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.Supplemental rationale.Supplemental rationale.Corrected data: b5, h10.14 events were originally reported for this failure mode during the reporting quarter.15 events should have been reported; 1 event was inadvertently excluded.- 15 reported events are included in this follow-up record.Product return status: 12 devices were received.3 device investigation types have not yet been determined.Event confirmation status: 11 reported events were confirmed.1 reported event was not confirmed.Evaluation results: 9 devices were found to be affected by a fatigued irrigation/pinch valve.1 device was found to be affected by faulty ultrasonic circuit board.1 device was found to be affected by faulty panel circuit board.1 device had no problem found.
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 15 previously reported events are included in this follow-up record.Product return status: 15 devices were received.Event confirmation status: 14 reported events were confirmed.1 reported event was not confirmed.Evaluation results: 12 devices were found to be affected by a fatigued irrigation/pinch valve.1 device was found to be affected by faulty ultrasonic circuit board.1 device was found to be affected by faulty panel circuit board.1 device had no problem found.
Event or Problem Description
This report summarizes noe 15 noe malfunction events in which the device experienced an irrigation issue that could lead to overheating.13 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 206-0 802; JP 206-0802
• MDR Report Key: 9245233
• Report Number: 0008043928-2019-00013
• Device Sequence Number: 1814576
• 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: 15
• 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): 07/29/2020

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: 09/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019; 09/30/2019
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 04/29/2020; 07/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1