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

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
The device was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus, the endoscopic instrument lubricant was used on the patient which was an off-label use.The customer used the lubricant to help pass the scope down the patient.The issue was found during an unknown procedure.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The device history record 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.Based on the results of the investigation, the root cause of the off label use was the customer used the lubricant to help pass the scope down the patient.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
**udi related data quality updates only** d4: lot number was documented as "unknown" and was intended to be "asku" as the information was requested, but unable to be provided.The d4 udi could not be provided in full due to the unknown lot number, therefore, the udi field only provided the di available.If additional information is received, a supplemental report will be submitted.

• Brand Name: ENDOSCOPIC INTRUMENT LUBRICANT, 3/PK
• Common Device Name: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18097506
• Report Number: 3011050570-2023-00177
• Device Sequence Number: 8051479
• Product Code: CCW
• UDI-Device Identifier: 00821925038110
• UDI-Public: 00821925038110
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/02/2024

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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2023
• Supplement Date Received by Manufacturer: 12/11/2023; 07/22/2024
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 01/01/2024; 08/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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