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

Catalog Number	550025B107
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting return of device to manufacturer.
Event or Problem Description
It was reported that during a surgical procedure, it was reported that the tip overheated and burned the surgeon.It was also reported there were no delays as a result of this event.It was further reported that the procedure was completed successfully.
Event or Problem Description
It was reported that during a surgical procedure, it was reported that the tip overheated and burned the surgeon.It was also reported there were no delays or medical intervention as a result of this event.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
H6: the quality investigation is complete.H3 other text : device not available for return.

• Brand Name: 11CM IQ 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: 15380580
• Report Number: 0001811755-2022-00037
• Device Sequence Number: 5613755
• Product Code: LFL
• UDI-Device Identifier: 37613327422482
• UDI-Public: 37613327422482
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K190070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2022

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 Catalogue Number: 550025B107
• 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: 08/11/2022
• Supplement Date Received by Manufacturer: 11/18/2022
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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