MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SONOPET IQ UNIVERSAL ANGLED HANDPIECE; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number 5500255000

Device Problem Inability to Irrigate (1337)

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

Event Date 06/30/2023

Event Type  malfunction  

Event Description

This report summarizes 1 malfunction event in which the device experienced an irrigation issue that could lead to overheating.1 event had no 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.Reported events: 1 event was reported for this quarter.Product return status: 1 device was received.Additional information: 1 device was not labeled for single-use.1 device was not reprocessed or reused.

• Brand Name: SONOPET IQ UNIVERSAL ANGLED HANDPIECE
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• 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: 17404018
• MDR Text Key: 320664849
• Report Number: 0001811755-2023-00117
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 07613327298611
• UDI-Public: 07613327298611
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 5500255000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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