MAUDE Adverse Event Report: GYRUS ACMI, INC. SEAL KIT, 6-12FR, 12/BOX; HYSTEROSCOPE (AND ACCESSORIES)

Model Number	CS-B612
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, the sterilization temperature is wrong in the brochure for the seal kit, 6-12fr, 12/box.The issue was found during reprocessing.The issue was resolved by sending the customer the updated ifu.There were no reports of patient harm.
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to correct e2, e3, and g2.A review of the device history record found no deviations.Based on the results of the investigation, the customer was provided an updated instructions for use.Olympus will continue to monitor field performance for this device.

• Brand Name: SEAL KIT, 6-12FR, 12/BOX
• Common Device Name: HYSTEROSCOPE (AND ACCESSORIES)
• 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: 18315616
• Report Number: 3011050570-2023-00215
• Device Sequence Number: 15125893
• Product Code: HIH
• UDI-Device Identifier: 00821925038318
• UDI-Public: 00821925038318
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K890328
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/29/2024

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: CS-B612
• Device Lot Number: AG
• 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: 11/17/2023
• Supplement Date Received by Manufacturer: 12/27/2023; 01/25/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 12/28/2023; 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CS-G5.
• Patient Sex: Unknown