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

Catalog Number	550025B315
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/31/2023
Type of Reportable Event	Serious Injury
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 surgery, the surgeon mistakenly contacted the sonopet tip on the vessel and the blood vessel was damaged.An angiorrhaphy was performed to repair the vessel.The procedure was completed successfully after a 60 minute delay.It was further reported that 1 week later, a subarachnoid hemorrhage happened.

• Brand Name: 12CM IQ MICRO CLAW
• 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: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 17834861
• Report Number: 3015967359-2023-02036
• Device Sequence Number: 7418506
• Product Code: LFL
• UDI-Device Identifier: 37613327422383
• UDI-Public: 37613327422383
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 550025B315
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 09/28/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown