MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP INTERPULSE HANDPIECE WITH HIGH FLOW TIP; LAVAGE, JET

Catalog Number 0210114000

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/31/2023

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 3 events were reported for this quarter.Product return status 2 devices were not available for evaluation.1 device investigation type has not yet been determined.Additional information 3 devices were labeled for single-use.3 devices were not reprocessed or reused.

Event Description

This report summarizes 3 malfunction events in which the device had debris in sterile package.- 3 events had no 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: h6, h10 3 previously reported events are included in this follow-up record.Product return status 1 device was received.2 devices were not available for evaluation.H3 other text : device not returned.

Event Description

This report summarizes 3 malfunction events in which the device had debris in sterile package.- 3 events had no patient involvement; no patient impact.

• Brand Name: INTERPULSE HANDPIECE WITH HIGH FLOW TIP
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615 ; * 00615
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 18557280
• MDR Text Key: 333472630
• Report Number: 3015967359-2024-00258
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 34546540673566
• UDI-Public: 34546540673566
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 3
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 0210114000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/31/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1