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

Model Number	5450850000
Medical Device Problem Codes	Inability to Irrigate (1337); Overheating of Device (1437)
Health Effect - Clinical Codes	Burn(s) (1757); Burn, Thermal (2530)
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: 1 event was reported for this quarter.Product return status: 1 device investigation type has not yet been determined.Additional information: 1 device is not labeled for single-use.1 device was not reprocessed or reused.
Event or Problem Description
This report summarizes 1 malfunction event in which the device reportedly experienced an irrigation issue that could lead to overheating and overheated.1 event had the patient receive a burn.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: 1 previously reported event is included in this follow-up record.Product return status: 1 device was received.Event confirmation status: 1 reported event was confirmed.Evaluation results: 1 device was found to be affected by a fatigued irrigation/pinch valve.
Event or Problem Description
This report summarizes 1 malfunction event in which the device reportedly experienced an irrigation issue that could lead to overheating and overheated.1 event had the patient receive a burn.

• 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: 9245916
• Report Number: 0008043928-2019-00017
• Device Sequence Number: 430264
• 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: 1
• 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): 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
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 07/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1