MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SONOPET IQ IRRIGATION SUCTION CASSETTE; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	5500573000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure for an acoustic neuroma the irrigation cassette was leaking.The account reported detecting an electrical burning smell and then the console stopped working.The procedure was completed successfully following a brief delay to retrieve back-up equipment.No medical intervention or adverse consequences were reported.
Event or Problem Description
It was reported that during a procedure for an acoustic neuroma the irrigation cassette was leaking.The account reported detecting an electrical burning smell and then the console stopped working.The procedure was completed successfully following a brief delay to retrieve back-up equipment.No medical intervention or adverse consequences were reported.
Additional Manufacturer Narrative
Additional information: d10, h4.

• Brand Name: SONOPET IQ IRRIGATION SUCTION CASSETTE
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9603210
• Report Number: 0001811755-2020-00092
• Device Sequence Number: 16693735
• Product Code: LFL
• UDI-Device Identifier: 37613327298636
• UDI-Public: 37613327298636
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/29/2020

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: 5500573000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 01/17/2020
• Supplement Report FDA Received Date: 07/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5500050000,SONOPET IQ CONSOLE,SN (B)(6); 5500255000,SONOPET IQ HANDPIECE,SN (B)(6)