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

Catalog Number 0210114000

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2019

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: 5 events were reported for this quarter.Product return status: 2 devices were received.3 device investigation types have not yet been determined.Event confirmation status: 2 reported events were confirmed.Evaluation results: 2 devices did not have a root cause established.Additional information: 5 devices were labeled for single-use.5 devices were not reprocessed and reused.

Event Description

This report summarizes 5 malfunction events in which the device was reportedly leaking.5 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 corrected data: h10 5 previously reported events are included in this follow-up record.Product return status 2 devices were received.2 devices were not available for evaluation.1 device investigation type has not yet been determined.Event confirmation status 2 reported events were confirmed.Evaluation results 2 devices did not have a root cause established.

Event Description

This report summarizes 5 malfunction events in which the device was reportedly leaking.5 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 corrected data: h10 5 previously reported events are included in this follow-up record.Product return status 3 devices were received.2 devices were not available for evaluation.Event confirmation status 3 reported events were confirmed.Evaluation results 1 device was found to be affected by a broken battery housing port.2 devices had no problem found.

Event Description

This report summarizes 5 malfunction events in which the device was reportedly leaking.5 events had patient involvement; no patient impact.

• Brand Name: INTERPULSE HANDPIECE WITH HIGH FLOW TIP
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615 ; PR 00615
• MDR Report Key: 9245004
• MDR Text Key: 173388205
• Report Number: 0001811755-2019-03409
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 34546540673566
• UDI-Public: 34546540673566
• Combination Product (y/n): N
• Number of Events Reported: 5
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 04/28/2020

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
• Device Operator: No Information
• Device Catalogue Number: 0210114000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/28/2019
• Supplement Dates Manufacturer Received: 09/30/2019; 09/30/2019
• Supplement Dates FDA Received: 01/27/2020; 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1