MAUDE Adverse Event Report: STRYKER SUCTION IRRIGATOR

Lot Number 17157FG2

Device Problems Corroded (1131); Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 07/28/2017

Event Type  malfunction  

Event Description

During surgery, a scrub tech noticed something drip from the bottom of the suction irrigator.This is a disposable item that is attached to an iv bag for irrigation.At the time of opening and handing off to the sterile field, the sterile packaging was intact and showed no evidence of contamination in the plastic packaging container.Upon investigation the battery component was opened up and the batteries showed corrosion.The battery itself wasn't expired but was oozing.The product comes in a sealed package, sterile.The staff checked the integrity of the package prior to the case.The package did not appear to have any abnormalities - no leakage noted on the package.

• Brand Name: SUCTION IRRIGATOR
• Type of Device: SUCTION IRRIGATOR
• Manufacturer (Section D): STRYKER
• MDR Report Key: 7024532
• MDR Text Key: 91912308
• Report Number: MW5073251
• Device Sequence Number: 1
• Product Code: GCX
• 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
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 17157FG2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR