AESCULAP STEAM STER LOCKS ORANGE US906

MAUDE Adverse Event Report

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..

Event Text Entries

[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


MAUDE Entry Details

Report Number8522174
MDR Report Key8522174
Date Received2019-04-17
Date of Report2019-04-12
Date of Event2019-04-11
Report Date2019-04-12
Date Reported to FDA2019-04-12
Date Reported to Mfgr2019-04-17
Date Added to Maude2019-04-17
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAESCULAP STEAM STER LOCKS ORANGE
Generic NameSTERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES
Product CodeKCT
Date Received2019-04-17
Model NumberUS906
Catalog NumberUS906
Lot Number585854-01
Device AvailabilityY
Device Age1 DA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerAESCULAP, INC.
Manufacturer Address3773 CORPORATE PARKWAY CENTER VALLEY PA 18034 US 18034


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-17

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