MAUDE Adverse Event Report: GETINGE DISINFECTION AB GETINGE; WASHER DISINFECTOR

Model Number 46-5

Device Problem Residue After Decontamination (2325)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/08/2014

Event Type  malfunction  

Event Description

A small piece of blue debris/substance was observed in a phacoemulsification hand piece after cleaning in a 46 series washer disinfector using a rack accessory (mis uo-module_mis modular - l shape with filter).This was observed 5-6 times at this facility.

Manufacturer Narrative

The specific model number of the washer disinfector 46-5t is not available in the us.However, the accessory rack that may be the potential source of the blue debris is utilized for all 46 series washer disinfectors that are available in the us.F/u report to be submitted.

• Brand Name: GETINGE
• Type of Device: WASHER DISINFECTOR
• Manufacturer (Section D): GETINGE DISINFECTION AB; ljungadalsgatan 11 (se-07); vaxjo 351 15; SW 351 15
• Manufacturer Contact: ljungadalsgatan 11; (se-07); vaxjo 351 1-5 ; 2725036
• MDR Report Key: 4458960
• MDR Text Key: 17579163
• Report Number: 9616031-2014-00005
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 46-5
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/08/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1