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

Catalog Number	0210112000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
This report summarizes 10 malfunction events in which the device was reportedly leaking.10 events had patient involvement; no patient impact.
Additional 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 or Problem Description
This report summarizes 10 malfunction events in which the device was reportedly leaking.10 events had patient involvement; no patient impact.
Event or Problem Description
This report summarizes 10 malfunction events in which the device was reportedly leaking.10 events had patient involvement; no patient impact.
Additional 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
• Common Device Name: 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
• Report Number: 3015967359-2022-00740
• Device Sequence Number: 4332457
• Product Code: FQH
• UDI-Device Identifier: 34546540144233
• UDI-Public: 34546540144233
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 10
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/31/2022
• Supplement Date Received by Manufacturer: 03/31/2022; 03/31/2022
• Initial Report FDA Received Date: 04/25/2022
• Supplement Report FDA Received Date: 07/26/2022; 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown