MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD NX STERILIZER; STERRAD EQUIPMENT (MLR)

Catalog Number 10033

Device Problem Use of Device Problem (1670)

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

Event Date 11/12/2015

Event Type  malfunction  

Event Description

A customer reported they have been processing a volk ssv miniquadxl model#: bco3441 in a sterrad nx unit.Per the manufacturer, the volk lens is not validated for use in sterrad systems.The volk lens was released for use.There is no report of infection, injury or harm to patient(s) associated with this issue.As a matter of policy, advanced sterilization products (asp) has decided to report this event since the device was released and used on patients and sterility cannot be guaranteed.

Manufacturer Narrative

(b)(4).Asp investigation summary: the investigation included a review of the device history record (dhr), service history, failure mode and effects analysis (fmea), and system risk analysis (sra).¿the dhr was reviewed.The unit met manufacturing specifications at the time of release and there were no issues related to this failure mode noted.¿the service history for this unit was reviewed for the past 6 months (05/16/2015 to 11/12/2015) and trending was not exceeded.¿the fmea revealed the risk priority number (rpn) scores are considered to be acceptable.¿the sra shows the risk for exposure to toxic or corrosive material to be "low." no parts were returned for further evaluation.Failure to follow the instructions for use (ifu) by processing a non-approved device is the most likely assignable cause.The account manager performed a site visit and educated the customer to follow the manufacturer ifu for processing devices in the future.The reported issue was resolved at the customer facility.The issue will be tracked and trended.

• Brand Name: STERRAD NX STERILIZER
• Type of Device: STERRAD EQUIPMENT (MLR)
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer Contact: joaquin kurz ; irvine, CA 92618
• MDR Report Key: 5287660
• MDR Text Key: 33235705
• Report Number: 2084725-2015-00587
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/12/2015

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: Health Professional
• Device Catalogue Number: 10033
• Other Device ID Number: 10033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/12/2015
• Initial Date FDA Received: 12/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1