MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO INTERPULSE HANDPIECE SET WITH SUCTION TUBING; LAVAGE, JET

Catalog Number	0210100000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	12/31/2019
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: 8 events were reported for this quarter.Product return status: 7 devices were received.1 device was not available for evaluation.Event confirmation status: 7 reported events were confirmed.Evaluation results: 7 devices were found to be affected by a broken battery port.Additional information: 8 devices were labeled for single-use.8 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 8 malfunction events in which the device was reportedly leaking.8 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: b5, h10 8 events were originally reported for this failure mode during the reporting quarter.- 1 event was inadvertently excluded.- 9 reported events are included in this follow-up record.Product return status 8 devices were received.1 device was not available for evaluation.Event confirmation status 8 reported events were confirmed.Evaluation results 8 devices were found to be affected by a broken battery housing port/stem.
Event or Problem Description
This report summarizes 9 malfunction events in which the device was reportedly leaking.9 events had patient involvement; no patient impact.

• Brand Name: INTERPULSE HANDPIECE SET WITH SUCTION TUBING
• Common Device Name: LAVAGE, JET
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9636407
• Report Number: 0001811755-2020-00146
• Device Sequence Number: 11460924
• Product Code: FQH
• UDI-Device Identifier: 34546540144219
• UDI-Public: 34546540144219
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 9
• 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): 04/29/2020

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: No Information
• Device Catalogue Number: 0210100000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 01/28/2020
• Supplement Report FDA Received Date: 04/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1