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

Model Number US906

Device Problems Device Ingredient or Reagent Problem (2910); Unexpected Color (4055)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2021

Event Type  malfunction  

Event Description

It was reported that there was an issue with an orange steam indicator.The indicator on the lock did not turn or only slightly turned.There was no patient involvement.Additional information has been requested.

Manufacturer Narrative

If additional information or investigation results become available, a supplemental report will be submitted.

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
• Type of Device: 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: 13236643
• MDR Text Key: 283676529
• Report Number: 2916714-2021-00238
• Device Sequence Number: 1
• Product Code: KCT
• UDI-Device Identifier: 05055049091927
• UDI-Public: 5055049091927
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K890759
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 10/31/2023
• Device Model Number: US906
• Device Catalogue Number: US906
• Device Lot Number: 613452-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2023
• 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 Number: 1