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

Model Number	5500050000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	12/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a cranial procedure at the user facility, the tip of the device damaged the patient¿s dura, unintentionally creating an opening in the dura that was required to be sutured.There was no clinically-insignificant delay with the procedure, and the procedure was completed successfully.
Additional Manufacturer Narrative
Awaiting for device return to manufacturer.
Additional Manufacturer Narrative
H6: the quality investigation is complete.H3 other text : product status unknown.
Event or Problem Description
It was reported that during a cranial procedure at the user facility, the tip of the device damaged the patient¿s dura, unintentionally creating an opening in the dura that was required to be sutured.There was no clinically-insignificant delay with the procedure, and the procedure was completed successfully.

• 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: 16096603
• Report Number: 3015967359-2023-00006
• Device Sequence Number: 6516471
• Product Code: LFL
• UDI-Device Identifier: 07613327364675
• UDI-Public: 07613327364675
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K213824
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2023

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 Model Number: 5500050000
• Device Catalogue Number: 5500050000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2022
• Supplement Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2020
• 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