MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-17 for AESCULAP STEAM STER LOCKS ORANGE US906 manufactured by Aesculap, Inc..
[142217603]
We had nine sets with the aesculap usa orange locks becoming un-locked after sterilization, cooling, and storage. The locks are designed to tolerate steam sterilization. This has happened before. Different instrument processors and supervisor assembled those sets. (b)(4), our sterilizer vendor, has checked the sterilizers and the sterilizers are staying within the required cycle parameters. This could hamper patient care and delay surgeries. The locks that failed have a slightly different color and feel thinner than those from batches or lot numbers that work properly. Manufacturer response for aesculap steam sterilizer lock, aesculap steam ster locks orange (per site reporter). They are looking into it. We think the device may have been made by a different manufacturer or plant resulting in thinner plastic not holding up to sterilization.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8522174 |
| MDR Report Key | 8522174 |
| Date Received | 2019-04-17 |
| Date of Report | 2019-04-12 |
| Date of Event | 2019-04-11 |
| Report Date | 2019-04-12 |
| Date Reported to FDA | 2019-04-12 |
| Date Reported to Mfgr | 2019-04-17 |
| Date Added to Maude | 2019-04-17 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AESCULAP STEAM STER LOCKS ORANGE |
| Generic Name | STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES |
| Product Code | KCT |
| Date Received | 2019-04-17 |
| Model Number | US906 |
| Catalog Number | US906 |
| Lot Number | 585854-01 |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP, INC. |
| Manufacturer Address | 3773 CORPORATE PARKWAY CENTER VALLEY PA 18034 US 18034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-17 |