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

Catalog Number 0210112000

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/31/2022

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: 10 events were reported for this quarter.Product return status: 10 device investigation types have not yet been determined.Additional information: 10 devices were labeled for single-use.10 devices were not reprocessed or reused.

Event Description

This report summarizes 10 malfunction events in which the device was reportedly leaking.10 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 10 previously reported events are included in this follow-up record.Product return status 3 devices were not available for evaluation.7 device investigation types have not yet been determined.Device not returned.

Event Description

This report summarizes 10 malfunction events in which the device was reportedly leaking.10 events had patient involvement; no patient impact.

Event Description

This report summarizes 10 malfunction events in which the device was reportedly leaking.10 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: h10.10 previously reported events are included in this follow-up record.Product return status 6 devices were received.4 devices were not available for evaluation.

• Brand Name: INTERPULSE HANDPIECE WITH SOFT TISSUE TIP
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615 ; * 00615
• 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: 14193167
• MDR Text Key: 289981094
• Report Number: 3015967359-2022-00740
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 34546540144233
• UDI-Public: 34546540144233
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 10
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/24/2022

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 Catalogue Number: 0210112000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/31/2022
• Initial Date FDA Received: 04/25/2022
• Supplement Dates Manufacturer Received: 03/31/2022; 03/31/2022
• Supplement Dates FDA Received: 07/26/2022; 10/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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