Catalog Number 10101 |
Device Problem
Chemical Problem (2893)
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Patient Problem
Corneal Edema (1791)
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Event Date 04/14/2016 |
Event Type
Injury
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Manufacturer Narrative
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This report is for patient (b)(6) 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 four 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.
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Event Description
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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 additonal 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.
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Manufacturer Narrative
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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.
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Search Alerts/Recalls
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