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U.S. Department of Health and Human Services

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

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AESCULAP INC. STEAM STER LOCKS ORANGE; INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS Back to Search Results
Model Number US906
Device Problem Unexpected Color (4055)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/12/2022
Event Type  malfunction  
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 transition to its post sterilization color.The complaint device has been returned to the manufacturer for evaluation.No patient involvement.
 
Manufacturer Narrative
Manufacturer evaluation: investigation on-going.Should relevant additional / investigation results become available, a supplemental medwatch report will be submitted.
 
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.
 
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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 Key14365952
MDR Text Key294137675
Report Number2916714-2022-00044
Device Sequence Number1
Product Code JOJ
UDI-Device Identifier05055049091927
UDI-Public5055049091927
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K890759
Number of Events Reported1
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 01/11/2023
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
Device Operator Health Professional
Device Expiration Date04/30/2022
Device Model NumberUS906
Device Catalogue NumberUS906
Device Lot Number594722-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/29/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/12/2022
Initial Date FDA Received05/11/2022
Supplement Dates Manufacturer Received12/12/2022
Supplement Dates FDA Received01/11/2023
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 Number1
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