MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD 100S STERILIZER; STERRAD EQUIPMENT (MLR)

Catalog Number 10101

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Load not recalled.

Event Description

A customer reported broken chamber plastics with their sterrad® 100s and it is unknown if the load was reprocessed prior to being released for use on a patient(s).This event is being reported as the load status is unknown.Although there is no report of patient injury or harm and no prior incidents have resulted in serious injury, advanced sterilization products (asp) has determined that this situation presents a potential risk of infection.Asp recognizes that in many cases it would be difficult to trace infection back to the sterilization.As a matter of policy asp has therefore decided to report cases of cancelled cycles if the complainant does not confirm that the load was reprocessed prior to use on a patient.

• Brand Name: STERRAD 100S 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: 5043772
• MDR Text Key: 25344957
• Report Number: 2084725-2015-00291
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K991999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Report Date: 08/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10101
• Device Lot Number: 083327
• Other Device ID Number: 10101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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