MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO STRAIGHT LARGE DIAMETER; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	5450800308
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that during a tumor removal surgery, the distal part of the irrigation sleeve melted.It was further reported that the irrigation sleeve cracked.It was also reported that there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
Updated manufacturing date based on manufacturer feedback.Device evaluation: investigation results indicate that the sleeve melted due to inadequate use of irrigation.The ifu of handpieces and console associated with this device warns the user against this type of use: "always use sufficient irrigation flow.Failure to comply may result in excessive heat and potential burn injury." the quality investigation is complete.
Event or Problem Description
It was reported that during a tumor removal surgery, the distal part of the irrigation sleeve melted.It was further reported that the irrigation sleeve cracked.It was also reported that there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.

• Brand Name: STRAIGHT LARGE DIAMETER
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8788940
• Report Number: 0001811755-2019-02279
• Device Sequence Number: 2638261
• Product Code: LFL
• UDI-Device Identifier: 37613252026687
• UDI-Public: 37613252026687
• Combination Product (Y/N): N
• Initial Reporter Country: SG
• PMA/510(K) Number: K010637
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2019

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 Expiration Date: 01/01/2021
• Device Catalogue Number: 5450800308
• Device Lot Number: M0014450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 07/15/2019
• Supplement Report FDA Received Date: 09/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1