MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 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 12/31/2021

Event Type  malfunction  

Event Description

This report summarizes 6 malfunction events in which the device was reportedly leaking.6 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.Reported events: 6 events were reported for this quarter.Product return status: 6 device investigation types have not yet been determined.Additional information: 6 devices were labeled for single-use.6 devices were not reprocessed or reused.

Event Description

This report summarizes 6 malfunction events in which the device was reportedly leaking.6 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: h10.6 previously reported events are included in this follow-up record.Product return status: 6 devices were not available for evaluation.H3 other text : device not available.

• Brand Name: INTERPULSE HANDPIECE WITH SOFT TISSUE TIP
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; highway #3, km 130.2; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; highway #3, km 130.2; kalamazoo MI 49001
• Manufacturer Contact: zach baker ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 13290678
• MDR Text Key: 284028157
• Report Number: 3015967359-2022-00105
• 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: 6
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/11/2022

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: 12/31/2021
• Initial Date FDA Received: 01/19/2022
• Supplement Dates Manufacturer Received: 12/31/2021
• Supplement Dates FDA Received: 04/11/2022
• 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