MAUDE Adverse Event Report: STRYKER CORPORATION INTERPULSE; LAVAGE, JET

Model Number 0210112000

Device Problem Crack (1135)

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

Event Date 03/03/2022

Event Type  malfunction  

Event Description

When opening the stryker interpulse pulsed lavage system, the package was cracked.The interpulse device made it to the back table, and, upon inspection of the back table, a piece of the package was found.

• Brand Name: INTERPULSE
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): STRYKER CORPORATION; 1941 stryker way; portage MI 49002
• MDR Report Key: 14345989
• MDR Text Key: 295251267
• Report Number: 14345989
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/15/2022

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 Model Number: 0210112000
• Device Catalogue Number: 0210112000
• Device Lot Number: 2166012
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/15/2022
• Date Report to Manufacturer: 05/10/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/10/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28105 DA