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	04/06/2022
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, 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.
Event or Problem Description
Investigation complete.
Additional Manufacturer Narrative
Manufacturing site evaluation: inspection of the returned product showed a slightly lighter and darker blue chemical indicator dot within the samples.It is unclear as to the source of the variation of color found in the finished devices.Testing of the returned product was conducted.The transition color seen in the exposed samples returned from the customer, a light blue/grey, was not able to be replicated in the internal testing.The darker indicators transitioned to the expected color when exposed to a sterilization process.The slightly lighter indicator dots did not transition as dark as expected, but still changed from the initial blue color.The device history records (dhr) were not able to be reviewed as no lot number was made available.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.The most likely root cause for unexpected color transition and stability could be the result of ineffective cycle conditions, improper storage, or inadvertent exposure to residual sterilant or chemicals.

• 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 ; 4847197287
• MDR Report Key: 14253155
• Report Number: 2916714-2022-00046
• Device Sequence Number: 17183358
• Product Code: JOJ
• UDI-Device Identifier: 05055049091927
• UDI-Public: 5055049091927
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 06/21/2023

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2022
• Supplement Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 06/21/2023
• 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