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	01/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer evaluation: investigation on-going.Should relevant additional / investigation results become available, a supplemental medwatch report will be submitted.
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, while in the sterile processing department (spd), the indicator dot failed to transition to its post sterilization color.The complaint device has not been returned to the manufacturer for evaluation.No patient involvement.
Additional Manufacturer Narrative
Manufacturer evaluation: the complaint device was not returned to the manufacturer for evaluation.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.However, the indicators on the us906 locks are sensitive to light and storage conditions.The us906 instructions for use (ifu) on the label states to store in a cool, dry place while maintaining temperatures between 15°c/60°f and 30°c/86°f.Significant changes in storage conditions for prolonged periods can have an adverse effect on the product.Although minor variations over short periods of time will have little or no effect on product, extreme storage conditions, such as exposure to direct sunlight and/or storage on top of or near heat source should be avoided.Us906 should not be used if the indicator dot color has changed prior to being processed.Adherence to the following guidelines will act to minimize recurrence of this failure mode: avoid prolonged exposure to direct sunlight or uv light.Avoid extreme temperature storage conditions.Avoid exposure to residual cleaning agents that may contain bleach, hydrogen peroxide, or other substances that could have an adverse impact to chemical indicators.Although the lot number of the lock was provided, the indicator lot # was not available.Therefore, the device history records (dhr) were not able to be reviewed.However, 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.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• 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 ; 3773 corporate parkway; center valley, PA 18034 ; 6109849072
• MDR Report Key: 13486823
• Report Number: 2916714-2022-00003
• Device Sequence Number: 17418457
• Product Code: JOJ
• UDI-Device Identifier: 05055049091927
• UDI-Public: 5055049091927
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 04/18/2023

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 Model Number: US906
• Device Catalogue Number: US906
• Device Lot Number: 594719-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2022
• Supplement Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 04/18/2023
• 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