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

Catalog Number 5500050000

Device Problem Inability to Irrigate (1337)

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

Event Date 06/30/2023

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events 3 events were reported for this quarter.Product return status 2 devices were received.1 device investigation type has not yet been determined.Additional information 3 devices were not labeled for single-use.3 devices were not reprocessed or reused.

Event Description

This report summarizes 3 malfunction events in which the device experienced an irrigation issue that could lead to overheating.- 2 events had no patient involvement; no patient impact.- 1 event had patient involvement; no patient impact.

Event Description

This report summarizes 3 malfunction events in which the device experienced an irrigation issue that could lead to overheating.- 2 events had no patient involvement; no patient impact.- 1 event had patient involvement; no patient impact.

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: g1, h6, h10 3 previously reported events are included in this follow-up record.Product return status 3 devices were received.

• Brand Name: SONOPET IQ ULTRASONIC ASPIRATOR CONSOLE
• 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: 17401350
• MDR Text Key: 320160905
• Report Number: 3015967359-2023-01639
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 07613327364675
• UDI-Public: 07613327364675
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 3
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 5500050000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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