MAUDE Adverse Event Report: GYRUS ACMI, INC. CF RESECTOSCOPE INNER SHEATH, 25FR; HYSTEROSCOPE

Model Number	EIS-HCF25
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found a broken tip.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 cf resectoscope inner sheath, 25fr has a broken, missing tip.The issue was found during reprocessing.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information obtained from the customer and results the approved final investigation.The device was manufactured in may 2022, but the specific date is unknown.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, as a ceramic material is brittle in nature, all ceramic tips are susceptible to fracture even though a more robust re-design was implemented back in march 2014.Potential damage to distal tip is addressed in the device instructions for use: - "study this manual and other labeling thoroughly for safe handling, storage and usage, including instructions for all generators and accessories.Failure to properly follow the instructions, warnings, and cautions may lead to serious surgical consequences or injury to the patient.Misuse of instruments can cause injury to the patient and could have an adverse effect on the procedure being performed.Do not drop instruments, or allow them to be struck by other objects." - " do not use an instrument that fails to meet the criteria stated in the labeling or that has been damaged.Damage may result in the loss of the entire ceramic tip or fragments of the ceramic tip.If there is evidence of charring, burn spots, chips or cracks in the ceramic tip or surrounding area, do not use." olympus will continue to monitor field performance for this device.

• Brand Name: CF RESECTOSCOPE INNER SHEATH, 25FR
• Common Device Name: HYSTEROSCOPE
• 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: 18081341
• Report Number: 3011050570-2023-00173
• Device Sequence Number: 7729897
• Product Code: HIH
• UDI-Device Identifier: 00821925001893
• UDI-Public: 00821925001893
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2023

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: EIS-HCF25
• Device Lot Number: DF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2023
• Supplement Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2022
• 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