MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 11CM IQ APEX KNIFE; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	550025B114
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Codes	Superficial (First Degree) Burn (2685); Insufficient Information (4580)
Date of Event	12/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, the sonopet iq tip got hot.The patient was burned on the face.The burn was located on the upper nose of the patient.It was approx 1cm in size.The doctor mentioned he may try to do "prp thereapy with micro needling".No infection was reported.The procedure was completed successfully.This report is for tip 1 of 2.
Additional Manufacturer Narrative
H6: a follow up report will be filed once the quality investigation is complete.H3 other text : device discarded.
Additional Manufacturer Narrative
H6: the quality investigation is complete.Device discarded.
Event or Problem Description
It was reported that during a procedure, the sonopet iq tip got hot.The patient was burned on the face.The burn was located on the upper nose of the patient.It was approx 1cm in size.The doctor mentioned he may try to do "prp therapy with micro needling".No infection was reported.The procedure was completed successfully.This report is for tip 1 of 2.

• Brand Name: 11CM IQ APEX KNIFE
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 16794441
• Report Number: 3015967359-2023-00778
• Device Sequence Number: 20719766
• Product Code: LFL
• UDI-Device Identifier: 37613327422499
• UDI-Public: 37613327422499
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K213824
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2024
• Device Catalogue Number: 550025B114
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2022
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown