MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO INTERPULSE IRRIGATION ONLY HANDPIECE; LAVAGE, JET

Catalog Number 0210200000

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2019

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 4 events were reported for this quarter.Product return status: 1 devices were not available for evaluation.3 device investigation type has not yet been determined.Additional information: 4 devices were labeled for single-use.4 devices were not reprocessed and reused.

Event Description

This report summarizes 4 malfunction events in which the device was reportedly leaking.4 events had patient involvement; no patient impact.

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: 4 previously reported events are included in this follow-up record.Product return status: 2 devices were received.2 devices were not available for evaluation.Event confirmation status: 2 reported events were confirmed.Evaluation results: 2 devices had no problem found.

Event Description

This report summarizes 4 malfunction events in which the device was reportedly leaking.4 events had patient involvement; no patient impact.

• Brand Name: INTERPULSE IRRIGATION ONLY HANDPIECE
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8816156
• MDR Text Key: 152092810
• Report Number: 0001811755-2019-02380
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 34546540144264
• UDI-Public: 34546540144264
• Combination Product (y/n): N
• Number of Events Reported: 4
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/03/2019

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
• Device Operator: No Information
• Device Catalogue Number: 0210200000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/24/2019
• Initial Date FDA Received: 07/23/2019
• Supplement Dates Manufacturer Received: 06/24/2019
• Supplement Dates FDA Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1