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

Model Number	AE-1
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Tac (technical assistance center) support engineer addressed the customer concern.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.The ae-1 lubricant will not be returned to olympus.The lot number of the lubricant is not available.To date, there are no reports of patient injury.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
The customer called in and inquired if olympus has a lubricant for the bf scopes for insertion, they are using ae-1.The issue found during an unspecified procedure.Customer stated they have been using ae-1 for years as a lubricant for patients.There was no patient harm or injury reported due to the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The dhr was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The case is not due to design.Based on the results of the investigation, there is no data to indicate that there is an increased severity or occurrence.A definitive root cause cannot be identified.Olympus will continue to monitor the field performance of this device.

• Brand Name: ENDOSCOPIC INTRUMENT LUBRICANT, 3/PK
• Common Device Name: ENDOSCOPIC INSTRUMENT LUBRICANT
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: kenneth pittman ; 93 north pleasant st.; norwalk, OH 44857 ; 9013785969
• MDR Report Key: 13012213
• Report Number: 1519132-2021-00023
• Device Sequence Number: 19286875
• Product Code: CCW
• UDI-Device Identifier: 00821925038110
• UDI-Public: 00821925038110
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K883819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AE-1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2021
• Supplement Date Received by Manufacturer: 12/16/2021
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown