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

Model Number US906

Device Problem Unexpected Color (4055)

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

Event Date 03/10/2022

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 transitioned to its post sterilization color, however, the indicator dot turned back to blue after approximately thrity (30) to sixty (60) days while in storage in the sterile processing department (spd).The lock was not in extreme temperatures while in sterile storage within the department.The containers are stored on normal shelving and are not exposed to intense light.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.A visual examination of the chemical indicator revealed that one (1) of the indicator dots was grey/blue and one (1) was light blue.Both dots were not consistent with the expected initial or final transition color.The device history records (dhr) were not able to be reviewed as no lot # 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 investigation into the cause of the reported problem was able to confirm the failure mode of chemical indicator failed to transition to its post sterilization color.

• 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 ; 3773 corporate parkway; center valley, PA 18034 ; 4847197287
• MDR Report Key: 14053537
• MDR Text Key: 289016528
• Report Number: 2916714-2022-00039
• Device Sequence Number: 1
• Product Code: JOJ
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: US906
• Device Catalogue Number: US906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2023
• 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