MAUDE Adverse Event Report: STRYKER MEDTECH SONOPET ANGLED HANDPIECE, UNIVERSAL; INSTRUMENT, ULTRASONIC SURGICAL

Model Number	5450820000
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	12/31/2019
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: 6 events were reported for this quarter.Product return status: 6 device investigation types have not yet been determined.Additional information: 6 devices were not labeled for single-use.6 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 6 malfunction events in which the device reportedly overheated.3 events had no patient involvement; no patient impact.3 events had patient involvement; no patient impact.
Event or Problem Description
This report summarizes 6 malfunction events in which the device reportedly overheated.3 events had no patient involvement; no patient impact.3 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 6 previously reported events are included in this follow-up record.Product return status 4 devices were received.2 device investigation types have not yet been determined.Event confirmation status.4 reported events were not confirmed.Evaluation results 4 devices had no problem found.
Event or Problem Description
This report summarizes 6 malfunction events in which the device reportedly overheated.3 events had no patient involvement; no patient impact.3 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 corrected data: h10 6 previously reported events are included in this follow-up record.Product return status 6 devices were received.Event confirmation status 6 reported events were not confirmed.Evaluation results 1 device was found to be affected by an overtorqued angle nut.5 devices had no problem found.

• Brand Name: SONOPET ANGLED HANDPIECE, UNIVERSAL
• 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: 9636490
• Report Number: 0008043928-2020-00001
• Device Sequence Number: 3171192
• Product Code: LFL
• UDI-Device Identifier: 07613327291919
• UDI-Public: 07613327291919
• 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,Followup
• Report Date (Section B): 07/30/2020

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: 5450820000
• Device Catalogue Number: 5450820000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 12/31/2019; 12/31/2019
• Initial Report FDA Received Date: 01/28/2020
• Supplement Report FDA Received Date: 04/29/2020; 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1