MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 12CM IQ STANDARD; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	550025S307
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	06/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure the patient received a third degree burn from the sonopet tip.The burn was excised and treated with monocryl.The procedure was completed successfully without a clinically significant delay.
Additional Manufacturer Narrative
H6: a follow up report will be filed once the quality investigation is complete.H3 other text : awaiting confirmation device is available for return.
Additional Manufacturer Narrative
H6: the quality investigation is complete.H3 other text : device not available for return.
Event or Problem Description
It was reported that during a procedure the patient received a third degree burn from the sonopet tip.The burn was excised and treated with monocryl.The procedure was completed successfully without a clinically significant delay.

• Brand Name: 12CM IQ STANDARD
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: colette chung ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 17343249
• Report Number: 3015967359-2023-01455
• Device Sequence Number: 6913119
• Product Code: LFL
• UDI-Device Identifier: 37613327422468
• UDI-Public: 37613327422468
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K190070
• 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): 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2024
• Device Catalogue Number: 550025S307
• Device Lot Number: 22299037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/19/2023
• Supplement Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 11/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown