MAUDE Adverse Event Report: STRYKER MEDTECH SONOPET 110V CONSOLE WITH FOOT PEDAL AND POLE; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number 5450850000

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 2 events were reported for this quarter.Product return status 2 devices were received.Additional information 2 devices were not labeled for single-use.2 devices were not reprocessed or reused.

Event Description

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

• Brand Name: SONOPET 110V CONSOLE WITH FOOT PEDAL AND POLE
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER MEDTECH; 1131-1 higashi naganuma; inagi 206-0 802; JA 206-0802
• Manufacturer (Section G): STRYKER MEDTECH; 1131-1 higashi naganuma; inagi 206-0 802; JA 206-0802
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 17402605
• MDR Text Key: 319831009
• Report Number: 0008043928-2023-00013
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 07613327291872
• UDI-Public: 07613327291872
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/26/2023

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: 5450850000
• 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