MAUDE Adverse Event Report: AESCULAP INC STEAM STER LOCKS ORANGE; PROCESS INDICATOR LOCK

Model Number US906

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2016

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site investigation is on-going.(b)(4).

Event Description

Country of complaint: usa.Customer reported that in the central sterile processing area it was observed that the orange locks dots are: turning back to blue after sterilized; (or) only partially turning brown/black; (and) the ink seems to be coming off the indicator dots.The customer stated that this caused a delay in surgery for maybe an hour because they had to reprocess sets again.They reported that they did have patients under anesthesia that had to remain under additional anesthesia while new trays were located or the trays were re-sterilized using iuss.The customer confirmed that other than additional anesthesia and or time there were no additional injuries to the patient.

Manufacturer Narrative

A retrospective review of potential serious injury complaints was performed.This mdr was identified and filed as part of the review activities.B5: clarification added.The complained product was not returned and the batch # was not provided.Due to the time frame, it was reasonable to assume that the product fell within the scope of the description noted below.Supplier: (b)(4).Actions taken: capa opened by aesculap inc.Corrective action: sps- in october 2016, a labeling change had been made to state that this product should be kept out of direct sunlight, away from heat sources, away from hydrogen peroxide, and other sterilants.Description: there were an increased number of complaints on the indicator dot labels reverting back to blue or not fully turning.The supplier was made aware of the complaints and various lots were investigated.During the investigation, ink manufacturing process was reviewed and verified.No changes, other than going to a lead-free ink were made in the process or to the raw materials associated with making this product.Additionally, a comprehensive review was conducted with the ink manufacturer on the chemical makeup of the ink.No changes were made or found.Lastly, multiple tests and studies were conducted in an attempt to determine the root cause of the issues being reported by customers.Conclusion: at this time the issues of reversion and inconsistent color change were able to be duplicated.Through testing it was found that both lead and lead-free indicator labels would be adversely affected by being exposed to hydrogen peroxide post-sterilization.In all test cases, a reversion would occur once the processed label was exposed to hydrogen peroxide.The lead-free indicator labels were adversely affected by the exposure to direct sunlight and hydrogen peroxide.In hydrogen peroxide exposure prior to sterilization, an inconsistent color change was experienced and led to a reversion over the course of testing.Additionally, exposure to direct sunlight has caused the indicator label to revert and fluorescent light has begun to fade these indicator labels.Lead indicator labels were not as sensitive to these exposure types but did show signs that these exposures affected the product.During pre-sterilization hydrogen peroxide exposure, it was found that the lead indicator labels displayed an inconsistent color change.Both direct sunlight and fluorescent light did not appear to adversely affect the product.Corrective action: see above.

Event Description

Clarification was received: there were delays in the start of surgeries while staff located replacement trays.Some patients were already under anesthesia; other than additional anesthesia time, there was no patient harm.

• Brand Name: STEAM STER LOCKS ORANGE
• Type of Device: PROCESS INDICATOR LOCK
• Manufacturer (Section D): AESCULAP INC; 3773 corporate parkway; center valley, pa
• MDR Report Key: 5818144
• MDR Text Key: 50296055
• Report Number: 2916714-2016-00618
• Device Sequence Number: 1
• Product Code: KCT
• Combination Product (y/n): N
• PMA/PMN Number: K944864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: US906
• Device Catalogue Number: US906
• Distributor Facility Aware Date: 06/21/2016
• Date Manufacturer Received: 11/09/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other