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

Model Number US906

Device Problems Improper Chemical Reaction (2952); Material Integrity Problem (2978)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2020

Event Type  malfunction  

Manufacturer Narrative

Note: a retrospective review of potential serious injury complaints was performed.This mdr was identified as a reportable malfunction as a result and filed as part of the review activities.

Event Description

It was reported there was an issue with the orange locks.The reporter indicated that instead of changing blue to brown, it looks more like a very light grey.This incident did not occur in surgery.This incident did not cause or contribute to serious injury or death or a delay in surgery.No additional intervention was mentioned.

Manufacturer Narrative

Additional information - d4 (udi), d7a, d8, d9 manufacturing site evaluation: the device was not available for physical evaluation by the manufacturer.Although no physical examination was performed, a similar investigation exists related to improper color transition of the indicator dots.To date, the reported ink failures have not been replicated without deviating from the product labeling or instructions for use.The device history records (dhr) were reviewed for the reported lot number; the device was found to be within specification at the time of production.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.Additionally, product retains from three (3) different lots, manufactured around the same time, were evaluated.All retains had been stored according to protocol prior to the testing.The processed retains transitioned correctly and were not discolored or faded.To date, the reported ink failures have not been replicated without deviating from the product labeling or instructions for use.Therefore, the likely root cause was determined to be improper storage conditions.Labeling is provided to guide the end user to avoid exposure to natural or uv lights, extreme heat sources, and residual sterilant.After usage the indicators should not be retained as a permanent record of exposure but rather a photo of the indicator should be utilized due to the indicators' sensitivity to light.The following guidelines should be followed to prevent this failure mode from occurring; · avoid prolonged exposure to direct sunlight or uv lighting.· avoid storage at or near any hydrogen peroxide sterilizer.· avoid exposure to residual cleaning agents that may contain bleach, hydrogen peroxide, or other substances that could have an adverse impact to chemical indicators.

• Brand Name: STEAM STER LOCKS ORANGE
• Type of Device: STERILE TECHNOLOGY
• Manufacturer (Section D): AESCULAP INC.; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 10012045
• MDR Text Key: 189443618
• Report Number: 2916714-2020-00151
• Device Sequence Number: 1
• Product Code: KCT
• Combination Product (y/n): N
• PMA/PMN Number: K890759
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• 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
• Device Lot Number: 596700-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1