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

Model Number	US906
Medical Device Problem Codes	Material Integrity Problem (2978); Unexpected Color (4055)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information or investigation results become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that there was an issue with a steam ster locks orange.It was noted that the orange locks does not change color when going through sterilization.Blue does not change to brown.Additional information was not provided.Associated medwatch-reports: 2916714-2021-00231 ((b)(4) - us906).
Additional Manufacturer Narrative
Manufacturer evaluation: although the device was returned by the complainant, the sample was lost during shipment.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.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: STERILE TECHNOLOGY
• 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: 12962049
• Report Number: 2916714-2021-00230
• Device Sequence Number: 20185885
• Product Code: KCT
• 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): 03/17/2023

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: 613453-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 03/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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