MAUDE Adverse Event Report: AESCULAP INC STEAM STER LOCKS ORANGE; STERILE TECHNOLOGY

Model Number	US906
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information or investigation results will be provided, if available.
Event or Problem Description
It was reported that there was an issue with orange indicator dot.According to the complaint description, the blue dot on the orange lock changed from blue to brown as expected during sterilization.Sometime later the indicator dot changed to white.There was no patient involvement.
Additional Manufacturer Narrative
Investigation results: as a lot number, photos, or returned product was not received, a targeted investigation could not occur.The complaint database was reviewed.As chemical indicators may be sensitive to environmental conditions, we do receive the occasional complaint for them.The complaint database will continue to be monitored for reoccurrence.It is important that steam indicator chemical indicators are stored correctly to ensure the product performs as expected.The product should be stored at 20 - 25°c average, with a relative humidity range of 30 - 70%.Avoid exposure to direct sunlight and/or heat sources.Store away from sterilants.Labeling is provided to guide the end user to avoid exposure to natural or uv lights, extreme heat sources, and residual sterilants.

• Brand Name: STEAM STER LOCKS ORANGE
• Common Device Name: STERILE TECHNOLOGY
• Manufacturer (Section D): AESCULAP INC; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 12365509
• Report Number: 2916714-2021-00168
• Device Sequence Number: 3974101
• Product Code: KCT
• UDI-Device Identifier: 05055049091927
• UDI-Public: 5055049091927
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K944864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2021

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 Model Number: US906
• Device Catalogue Number: US906
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/30/2021
• Supplement Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1