MAUDE Adverse Event Report: STRYKER INSTRUMENTS,DIV OF STRYKER CORP. INTERPULSE HANDPIECE SET W/HIGH FLOW; LAVAGE, JET, SYSTEM

Catalog Number 210-114

Device Problem Failure to Power Up (1476)

Patient Problem No Information (3190)

Event Date 07/23/2014

Event Type  malfunction  

Event Description

The interpulse was opened onto the back table.When it was plugged into the fluid and hooked to suction it would not turn on.The battery compartment was opened and checked.It still would not function.A new interpulse was opened and used to complete procedure without any issues.

• Brand Name: INTERPULSE HANDPIECE SET W/HIGH FLOW
• Type of Device: LAVAGE, JET, SYSTEM
• Manufacturer (Section D): STRYKER INSTRUMENTS,DIV OF STRYKER CORP.; 4100 east milham ave; kalamazoo MI 49001
• MDR Report Key: 4251045
• MDR Text Key: 16452397
• Report Number: 4251045
• 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
• Type of Report: Initial
• Report Date: 11/06/2014

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: Nurse
• Device Catalogue Number: 210-114
• Device Lot Number: 141040012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/06/2014
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/06/2014
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 82