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

Model Number 210-118-700 REV-E

Device Problem Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 09/26/2014

Event Type  malfunction  

Event Description

The product would not work after plugged in.

• Brand Name: INTERPULSE HANDPIECE SET
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): STRYKER INSTRUMENTS; 2825 airview blvd; portage MI 49002
• MDR Report Key: 4212545
• MDR Text Key: 5153246
• Report Number: 4212545
• Device Sequence Number: 1
• Product Code: FQH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/20/2014

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 Operator: Unknown
• Device Model Number: 210-118-700 REV-E
• Device Catalogue Number: H8190 210-118-100
• Device Lot Number: 3161201141140124
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/20/2014
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/20/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1