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

Catalog Number 10101

Device Problem Positioning Problem (3009)

Patient Problem Burn(s) (1757)

Event Date 03/28/2016

Event Type  Injury  

Manufacturer Narrative

A field service engineer (fse) was dispatched to customer site.The shelf pack was reinstalled.The unit was returned to service.

Event Description

A customer reported a hand burn from a sterrad 100s.No load was involved in this issue.The duration and severity of the burn is also unknown.The circumstances of how the issue occurred is also unknown at this time.An asp field service engineer was dispatched to assess the unit onsite.Asp will continue to follow up for additional information.

Manufacturer Narrative

Additional information was received from the asp china affiliate stating the duration of healthcare worker's symptoms lasted 10 minutes.They flushed the affected area with water.It is unknown whether or not the healthcare worker was wearing personal protective equipment (ppe).This is not considered a serious injury and is not a reportable event.

• 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: 5611611
• MDR Text Key: 43770507
• Report Number: 2084725-2016-00240
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K991999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 10101
• Device Lot Number: 10101073006
• Other Device ID Number: 10101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2007
• 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