MAUDE Adverse Event Report: AESCULAP INC. STEAM STER LOCKS ORANGE; INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS

Model Number US906

Device Problem Unexpected Color (4055)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/11/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturer evaluation: investigation on-going.Should relevant additional / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

It was reported to aesculap inc.That a steam ster locks orange (part # us906) was used to secure a sterilization container.According to the complainant, the indicator dot failed to consistently transition to its post sterilization color.Reportedly, one side of the lock would change color, but the blue mark on the other side would not completely transition.Color would not even partially change from blue to black.The set was pulled, the lock was changed, and the instruments were re-sterilized.The complaint device has been returned to the manufacturer for evaluation.No patient involvement.

Manufacturer Narrative

Manufacturer evaluation: the device was returned to the manufacturer for physical evaluation.Functional testing was performed by exposing twelve (12) of the locks to steam cycles; a visual examination of the chemical indicator revealed that all dots transitioned from blue to brown.The device history records (dhr) were reviewed for all available lot numbers; the devices were found to be within specification at the time of production.All device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.The investigation into the cause of the reported problem was not able to confirm the failure mode of chemical indicator failed to transition to its post sterilization color.

• Brand Name: STEAM STER LOCKS ORANGE
• Type of Device: INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS
• Manufacturer (Section D): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• Manufacturer (Section G): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• Manufacturer Contact: jonathan severino ; 861 marcon boulevard; allentown, PA 18109 ; 4847197287
• MDR Report Key: 12821537
• MDR Text Key: 282582753
• Report Number: 2916714-2021-00212
• Device Sequence Number: 1
• Product Code: JOJ
• UDI-Device Identifier: 05055049091927
• UDI-Public: 5055049091927
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K890759
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: US906
• Device Catalogue Number: US906
• Device Lot Number: 2104017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2021
• Initial Date FDA Received: 11/16/2021
• Supplement Dates Manufacturer Received: 01/25/2023
• Supplement Dates FDA Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1