MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SONOPET IQ ULTRASONIC ASPIRATOR CONSOLE; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	5500050000
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The user from user facility reported that during a procedure, the device had lack of aspiration that resulted in reschedule of the procedure.This report is being submitted for the rescheduled procedure.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
Event or Problem Description
The user from user facility reported that during a procedure, the device had lack of aspiration that resulted in reschedule of the procedure.This report is being submitted for the rescheduled procedure.

• Brand Name: SONOPET IQ ULTRASONIC ASPIRATOR CONSOLE
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 19487945
• Report Number: 3015967359-2024-01132
• Device Sequence Number: 7090138
• Product Code: LFL
• UDI-Device Identifier: 07613327364675
• UDI-Public: 07613327364675
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K213824
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 5500050000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown