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

Model Number 0210110000

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 08/15/2022

Event Type  malfunction  

Event Description

I was opening a stryker interpulse handpiece set (b)(4) to the sterile field, and found the set to have a grainy, sandy like sediment on the tubing.I threw the tubing away and found a new set to open, but it also had the same grainy, sandy sediment on the tubing, and i threw this set away as well.

• Brand Name: INTERPULSE
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): STRYKER INSTRUMENTS; 1941 stryker way; portage MI 49002
• MDR Report Key: 15758746
• MDR Text Key: 303305423
• Report Number: 15758746
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0210110000
• Device Catalogue Number: 0210-110-000
• Device Lot Number: 22174042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/01/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/09/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 259880 DA
• Patient Sex: Male
• Patient Weight: 95 KG