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

Model Number	US906
Medical Device Problem Code	Unexpected Color (4055)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2022
Type of Reportable Event	Malfunction
Event or Problem 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 transition to its post sterilization color.The complaint device has been returned to the manufacturer for evaluation.No patient involvement.
Additional Manufacturer Narrative
Manufacturer evaluation: investigation on-going.Should relevant additional / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Manufacturer evaluation: the device was returned to the manufacturer for physical evaluation.Functional testing was performed by exposing ten (10) of the locks to steam cycles; a visual examination of the chemical indicator revealed that all dots transitioned from blue to brown.Us906 is assigned a three (3) year expiration.The expiration date reflected on the bag of returned material was 30apr2022.The product was past its expiration when received for complaint investigation testing.Color transition may be less reactive as the indicator nears and passes the end of its lifetime.The color will change from blue to indicate exposure to a steam process, transitioning to a grey/blue color rather than darker brown/charcoal color in this instance.Storage conditions can also affect the final transition color.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 reported event of indicator dot failed to transition properly was not able to be confirmed.Therefore, the most likely root cause was determined to be end user storage conditions or end user equipment.

• Brand Name: STEAM STER LOCKS ORANGE
• Common Device Name: 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: 14365952
• Report Number: 2916714-2022-00044
• Device Sequence Number: 20247275
• Product Code: JOJ
• UDI-Device Identifier: 05055049091927
• UDI-Public: 5055049091927
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K890759
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: US906
• Device Catalogue Number: US906
• Device Lot Number: 594722-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 12/12/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown