MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP SONOPET IQ UNIVERSAL ANGLED HANDPIECE; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	5500255000
Medical Device Problem Codes	Accessory Incompatible (1004); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : device not available/returned for evaluation.
Event or Problem Description
The user facility reported that the device stopped working (displayed an error code) during a procedure.A surgical delay of at least two hours was reported.The procedure was completed successfully using manual instrumentation with no medical intervention reported.This report is being submitted due to the prolongation of the surgical procedure.

• Brand Name: SONOPET IQ UNIVERSAL ANGLED HANDPIECE
• 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: 18856133
• Report Number: 3015967359-2024-00467
• Device Sequence Number: 19667720
• Product Code: LFL
• UDI-Device Identifier: 07613327298611
• UDI-Public: 07613327298611
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K190070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/07/2024

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: 5500255000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2022
• 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