MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 18CM IQ MICRO CLAW; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	550025B303
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to use, it was noted that the tip sleeve had melted.It was further reported that this event did not occur during a surgical procedure and there was no delay, adverse consequences or medical intervention as a result of this event.
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting return of device to manufacturer.
Additional Manufacturer Narrative
H6: the quality investigation is complete.H3 other text : device not returned.
Event or Problem Description
It was noted that the tip sleeve had melted.It was further reported that this event did not occur while in the patient.The procedure was completed successfully and there was no delay, adverse consequences or medical intervention as a result of this event.

• Brand Name: 18CM IQ MICRO CLAW
• 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: 15854614
• Report Number: 0001811755-2022-00065
• Device Sequence Number: 12341746
• Product Code: LFL
• UDI-Device Identifier: 37613327422451
• UDI-Public: 37613327422451
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 01/25/2023

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
• Device Catalogue Number: 550025B303
• Device Lot Number: 21661017
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2022
• Supplement Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 11/23/2022
• Supplement Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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