MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO INTERPULSE HANDPIECE WITH HIGH FLOW TIP; LAVAGE, JET

Catalog Number	0210114000
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/24/2019
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 2 events were reported for this quarter.Product return status 2 device investigation type has not yet been determined.Additional information 2 devices were labeled for single-use.2 devices were not reprocessed and reused.
Event or Problem Description
This report summarizes 2 malfunction events in which the device had debris in sterile package.2 events had 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: h10 2 previously reported events are included in this follow-up record.Product return status 2 devices were received.Event confirmation status 2 reported events were confirmed.Evaluation results 1 device was found to be affected by a broken package.1 device was found to be affected by a manufacturing process issue.
Event or Problem Description
This report summarizes 2 malfunction events in which the device had debris in sterile package.2 events had patient involvement; no patient impact.

• Brand Name: INTERPULSE HANDPIECE WITH HIGH FLOW TIP
• Common Device Name: LAVAGE, JET
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8816451
• Report Number: 0001811755-2019-02441
• Device Sequence Number: 343679
• Product Code: FQH
• UDI-Device Identifier: 34546540673566
• UDI-Public: 34546540673566
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 2
• 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): 01/02/2020

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: No Information
• Device Catalogue Number: 0210114000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 01/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1