MAUDE Adverse Event Report: STRYKER CORP. STRYKER INTERPULSE HANDPIECE SET IRRIGATION DEVICE; LAVAGE, JET

Catalog Number 0210-114-100

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Type  No Answer Provided  

Event Description

Stryker interpulse irrigation system was to be used.This product was spiked with 1l bag of normal saline for irrigation.The first assist notice something dripping from the battery pack.Product taken off field and battery pack opened to find irrigation leak into the battery pack.This product was not used on a pt.Fda safety report id# (b)(4).

• Brand Name: STRYKER INTERPULSE HANDPIECE SET IRRIGATION DEVICE
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): STRYKER CORP.
• MDR Report Key: 8683181
• MDR Text Key: 147577666
• Report Number: MW5087210
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2020
• Device Catalogue Number: 0210-114-100
• Device Lot Number: 18338012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/07/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1