MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-11 for STERRAD? 100S CASSETTE 10113 manufactured by Advanced Sterilization Products.
[185499891]
Asp complaint ref #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185499892]
A customer reported an expired cassette was used with their sterrad? 100s sterilizer and three cycles were run and released for use. The sterrad? 100s sterilizer had not been in use since (b)(6) 2019. On (b)(6) 24, 2020, the sterrad? 100s was powered back on due to another sterilizer that was not operating. The customer stated that after the last of the three cycles were run and while removing the cassette from the sterilizer, the customer noticed the use by date on the cassette was (b)(6) 2019 and was expired. The cassette had been sitting in the sterrad since october when it was last used and did not eject from the sterrad prior to use. All items in the loads were then recalled and reprocessed except two items, a rigid telescope and a camera and light lead which had been released and used on patients. The customer stated they had used a biological with the released load and the biological test result was negative and passed. There was no report of infection, injury or harm to patient(s) associated with this issue. 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 in this situation sterility cannot be assured. Therefore, as a matter of policy asp had decided to report when a customer uses expired product and when the load has been released and used on patient(s) prior to reprocessing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2084725-2020-00011 |
| MDR Report Key | 9696121 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-11 |
| Date of Report | 2020-01-24 |
| Date of Event | 2020-01-24 |
| Date Mfgr Received | 2020-01-24 |
| Date Added to Maude | 2020-02-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. GABRIELA MCLELLAN |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9495030264 |
| Manufacturer G1 | ADVANCED STERILIZATION PRODUCTS |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERRAD? 100S CASSETTE |
| Generic Name | STERRAD EQUIPMENT |
| Product Code | MLR |
| Date Received | 2020-02-11 |
| Model Number | 10113 |
| Catalog Number | 10113 |
| Lot Number | 18L019 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADVANCED STERILIZATION PRODUCTS |
| Manufacturer Address | 33 TECHNOLOGY DRIVE IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-11 |