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

Catalog Number	5450820000
Medical Device Problem Code	Inability to Irrigate (1337)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2023
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 was received.Additional information 1 device was 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 experienced an irrigation issue that could lead to overheating.- 1 event had no patient involvement; no patient impact.

• 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; JA 206-0802
• Manufacturer (Section G): STRYKER MEDTECH; 1131-1 higashi naganuma; inagi 206-0 802; JA 206-0802
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 17401355
• Report Number: 0008043928-2023-00015
• Device Sequence Number: 6008009
• 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: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/26/2023

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 Catalogue Number: 5450820000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2023
• Initial Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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