MAUDE Adverse Event Report: AESCULAP, INC. AESCULAP STEAM STER LOCKS ORANGE; STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES

Model Number US906

Device Problem Protective Measures Problem (3015)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/11/2019

Event Type  malfunction  

Event Description

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.

• Brand Name: AESCULAP STEAM STER LOCKS ORANGE
• Type of Device: STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES
• Manufacturer (Section D): AESCULAP, INC.; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 8522174
• MDR Text Key: 142217603
• Report Number: 8522174
• Device Sequence Number: 1
• Product Code: KCT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: US906
• Device Catalogue Number: US906
• Device Lot Number: 585854-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1