MAUDE Adverse Event Report: GYRUS ACMI, INC ENDOSCOPIC INSTRUMENT LUBRICANT, 3/PK

Model Number AE-1

Device Problem Off-Label Use (1494)

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

Event Date 03/02/2021

Event Type  malfunction  

Manufacturer Narrative

The ae-1 lubricant will not be returned to olympus.The lot number of the lubricant is not available.The customer has been made aware that the ae-1 lubricant "is not intended for patient contact" and was provided a letter stating such as well as the msds for the product.To date, there are no reports of patient injury.This report will be supplemented accordingly following investigations.

Event Description

It was reported that the customer have been using the ae-1 to lubricate the bronchoscope to glide through ett¿s (endotracheal tube).The lubricant is being used on the exterior of the bronchoscope as a lubricant for easy passage into ett and placement of double lumen ett for thoracic surgery one lung ventilation.This lubricant is intended only for silicone lubricant for endoscopic stopcock valves.It is not intended for patient contact.There was no patient harm or user injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.Based on information provided by the customer, ae-1 lubricant was being used off-label.In response to the inquiry, the ae-1 customer letter and msds have been provided to the customer.In addition, the customer has been advised to follow the intended use stated in the ae-1 customer letter that the ae-1 lubricant is intended specifically as a silicone lubricant for endoscopic stopcock valves.It is not intended for patient contact.Dhr review was not conducted due to unknown lot number.Olympus will continue to monitor complaints for this device.

• Brand Name: ENDOSCOPIC INSTRUMENT LUBRICANT, 3/PK
• Type of Device: ENDOSCOPIC INSTRUMENT LUBRICANT, 3/PK
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11586092
• MDR Text Key: 243925919
• Report Number: 1519132-2021-00007
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 00821925038110
• UDI-Public: 00821925038110
• Combination Product (y/n): N
• PMA/PMN Number: K883819
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AE-1
• Device Catalogue Number: AE-1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1