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

Catalog Number 10101

Device Problem Chemical Problem (2893)

Patient Problem Corneal Edema (1791)

Event Date 04/14/2016

Event Type  Injury  

Manufacturer Narrative

This report is for patient (b)(4) who reported moderate corneal edema.(b)(4) are related complaints from the same facility.Asp has decided to report this event since it is unknown whether or not the sterrad® 100s sterilizer contributed to this event.This is five of seven 3500a reports being submitted for a serious injury event.Please reference manufacturer report numbers: 2084725-2016-00271, 2084725- 2016-00272, 2084725-2016-00273, 2084725-2016-00278, 2084725-2016-00279, 2084725-2016-00280 and 2084725-2016-00281.

Event Description

The customer reported seven patients underwent phacoemulsification cataract surgery on (b)(6) 2016, and six of the seven patients reported moderate to severe reactions.The instruments used in the procedure were sterilized in a sterrad® 100s sterilizer.The first patient reported having no post-operative reaction.Three patients had a severe reaction within 24 hours of the surgery, and the remaining three patients had moderate swelling.The customer also stated patients that had surgeries performed by other surgeons the same day had mild to moderate corneal decompensation.It is unknown, if any, whether or not any medications were prescribed to treat the symptoms and whether or not the patients have recovered.The customer states their pre-cleaning methods included washing of the instruments with an enzymatic cleaner (non-asp enzymatic cleaner), and rinsing with water before placing into the sterrad® 100s sterilizer.They report the cycle completed successfully without interruption.No additional information is available at this time.Asp will continue to follow-up for additional information regarding the event and the status of each affected patient.

Manufacturer Narrative

Asp investigation summary: the investigation included a review of the device history record (dhr), failure mode and effects analysis (fmea), and system risk analysis (sra).The dhr was reviewed and no issues relating the failure mode were noted.The involved unit met manufacturer specifications at the time of release.The fmea revealed the risk priority number (rpn) is at an acceptable level.The sra shows the risk for exposure to biohazardous, pathogenic or infectious material to be "low." the status of the patient is unknown as several attempts were made to gather this information and were unsuccessful.The sterrad® sterility guide could not be reviewed to confirm compatibility as the manufacturer and model number of the device was not available after multiple follow-ups.However, the sterrad® 100s guidelines recommend the lumen diameter of an instrument to be 1mm or greater for proper cleaning and disinfection.The phaco handpiece was less than 0.5 mm.Therefore, likely cause could be attributed peroxide being left in the lumens due to its size.The customer has been re-trained on appropriate use of the sterrad® 100s unit and no further issues have been reported.The issue was resolved at the customer facility.Asp will continue to track and trend this issue.

• 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: 5645671
• MDR Text Key: 44884245
• Report Number: 2084725-2016-00279
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 04/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 0101150450
• Other Device ID Number: 10101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/27/2016
• Initial Date FDA Received: 05/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2015
• 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