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

Catalog Number	550025B303
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/13/2021
Type of Reportable Event	Serious Injury
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 of a trans-maxillary approach to cranial base, the tip of the device overheated melting the plastic sleeve.It was also reported that the overheating caused burns to the patient and surgical site requiring an additional procedure to repair.It was further reported that the procedure was completed successfully.
Event or Problem Description
It was reported that during a surgical procedure of a trans-maxillary approach to cranial base, the tip of the device overheated melting the plastic sleeve.It was also reported that the overheating caused burns to the patient and surgical site requiring an additional procedure to repair.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
H6: the quality investigation is complete.

• 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
• MDR Report Key: 11340203
• Report Number: 0001811755-2021-00608
• Device Sequence Number: 11649057
• Product Code: LFL
• UDI-Device Identifier: 37613327422451
• UDI-Public: 37613327422451
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K190070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2021

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: 01/01/2022
• Device Catalogue Number: 550025B303
• Device Lot Number: 20029027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 03/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention