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

Catalog Number	5500573000
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned.
Event or Problem Description
It was reported that during a surgery a nurse noted the tubing was kinked.The procedure was completed successfully with no delay, medical intervention, or adverse consequences reported.

• 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: 10337832
• Report Number: 0001811755-2020-01998
• Device Sequence Number: 14219405
• Product Code: LFL
• UDI-Device Identifier: 37613327298636
• UDI-Public: 37613327298636
• Combination Product (Y/N): N
• Initial Reporter Country: JP
• PMA/510(K) Number: K190070
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• 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
• Device Lot Number: 19323012
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2020
• Initial 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