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 2019-12-23 for STERRAD? 100S STERILIZER 10101 manufactured by Advanced Sterilization Products.
[182560479]
(b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[182560480]
A customer reported a cycle cancellation with their sterrad? 100s sterilizer and the cancelled cycle was released for use on patients prior to reprocessing. There is no report of infection, injury or harm to patient(s) associated with this issue. Although there is no report of patient injury or harm, advanced sterilization products (asp) has determined in this situation sterility cannot be assured. Therefore, asp has decided to report all incidents of loads that are released from cancelled cycles prior to reprocessing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2084725-2019-01024 |
| MDR Report Key | 9511753 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-23 |
| Date of Report | 2019-11-28 |
| Date of Event | 2019-11-27 |
| Date Mfgr Received | 2020-03-16 |
| Date Added to Maude | 2019-12-23 |
| 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 | 949453-639 |
| 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 STERILIZER |
| Generic Name | STERRAD EQUIPMENT |
| Product Code | MLR |
| Date Received | 2019-12-23 |
| Model Number | 10101 |
| Catalog Number | 10101 |
| Device Availability | N |
| Device Age | DA |
| 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 | 2019-12-23 |