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

Catalog Number 0210112000

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2020

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: 3 devices were received.1 device investigation type has not yet been determined.Event confirmation status: 3 reported events were confirmed.Evaluation results: 3 devices were found to be affected by a broken battery housing port/stem.4 devices were labeled for single-use.4 devices were not reprocessed or reused.

Event Description

This report summarizes 4 malfunction events in which the device was reportedly leaking.1 event had no patient involvement; no patient impact.3 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: b5, h10 4 previously reported events are included in this follow-up record.Product return status 3 devices were received.1 device was not available for evaluation.Event confirmation status 3 reported events were confirmed.Evaluation results 3 devices were found to be affected by a broken battery housing port/stem.

Event Description

This report summarizes 4 malfunction events in which the device was reportedly leaking.1 event had no patient involvement; no patient impact.3 events had patient involvement; no patient impact.

• Brand Name: INTERPULSE HANDPIECE WITH SOFT TISSUE TIP
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9997196
• MDR Text Key: 188902018
• Report Number: 0001811755-2020-01073
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 34546540144233
• UDI-Public: 34546540144233
• 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: 10/29/2020

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
• Device Operator: No Information
• Device Catalogue Number: 0210112000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/24/2020
• Supplement Dates Manufacturer Received: 03/31/2020
• Supplement Dates FDA Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1