MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO DISPOSABLE TUBING SET AND EXTENDER FILTER TUBING; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	5450850003
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 1 event was reported for this quarter.  product return status: 1 device was received.Evaluation status: 1 device evaluation is in progress.Additional information: 1 device is labeled for single-use.1 device was not reprocessed and reused.
Event or Problem Description
This report summarizes 1 malfunction event in which the device had a black substance in the packaging.1 event had no patient involvement; no patient impact.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: 1event was previously reported during the reporting quarter; however:  - 1 event was reported in error.- 0 total events were reported for this catalog number/device code combination for the reporting quarter.
Event or Problem Description
This report summarizes 0 malfunction event in which the device had a black substance in the packaging.0 event had no patient involvement; no patient impact.

• Brand Name: DISPOSABLE TUBING SET AND EXTENDER FILTER TUBING
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8284720
• Report Number: 0001811755-2019-00247
• Device Sequence Number: 13973476
• Product Code: LFL
• UDI-Device Identifier: 04546540716200
• UDI-Public: 4546540716200
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2019

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: No Information
• Device Catalogue Number: 5450850003
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/25/2018
• Supplement Date Received by Manufacturer: 12/25/2018
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1