MAUDE Adverse Event Report: AESCULAP AG 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 08/01/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Country of complaint: usa.It was reported on (b)(6)2017 that orange locks were processed and not changing from blue to dark brown/ black.The staff had to re-sterilize tray causing the delay.Discovered in central sterile.No patient harm reported.Surgical delay of 1 hour reported.Due to updated information provided on 31-aug-2017 there was an hour (1) delay in surgery and the patient was under anesthesia during delay.

Manufacturer Narrative

No lot information, samples, or cycle parameters were available for additional analysis of this failure mode.Steam indicator dots are manufactured with an ink specifically designed to transition from blue to brown/black when exposed to steam sterilants.Dots are routinely tested to ensure product operates as intended during the manufacturing process, and undergo strict criteria for product release.Product is also subject to deliberate fail cycles, to demonstrate the devices ability to also fail as intended, prior to product release.The failure of the suspect device to transition to a signal color is indicative of a failed steam sterilization cycle, with the product operating as intended.As no details can be provided for lot traceability, or samples provided for analysis, this investigation is inconclusive.

• Brand Name: STEAM STER LOCKS ORANGE
• Type of Device: PROCESS INDICATOR LOCK
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 6835976
• MDR Text Key: 84426933
• Report Number: 2916714-2017-00022
• 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: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: US906
• Device Catalogue Number: US906
• Distributor Facility Aware Date: 08/31/2017
• Date Manufacturer Received: 10/03/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other