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

Catalog Number 5500255000

Device Problems Accessory Incompatible (1004); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2024

Event Type  Injury  

Manufacturer Narrative

H3 other text : device not available/returned for evaluation.

Event 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
• Type of Device: 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
• MDR Text Key: 337106602
• Report Number: 3015967359-2024-00467
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 07613327298611
• UDI-Public: 07613327298611
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K190070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 5500255000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other