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

Model Number	REXEIS-HCF25
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus that the cf resectoscope inner sheath, 25fr had a broken tip.The event occurred during reprocessing.There was no patient harm associated with the event.
Additional Manufacturer Narrative
The device was returned and evaluated, and the customer¿s allegation was confirmed.There were no additional findings.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
Additional Manufacturer Narrative
This report is being supplemented to correct the device model number and udi.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device was manufactured in september 2014, 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, the damage which occurred was most likely due to user mishandling during device reprocessing, such as impact/dropped.As a ceramic material is brittle in nature, all ceramic tips are susceptible to fracture even though a more robust re-design has been implemented.Potential damage to distal tip is addressed in the device instructions for use which state: "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 (AND ACCESSORIES)
• Manufacturer (Section D): GYRUS ACMI, INC.; 93 north pleasant st.; norwalk OH 44857
• Manufacturer (Section G): GYRUS ACMI, INC.; 93 north pleasant st.; norwalk OH 44857
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18229327
• Report Number: 1519132-2023-00019
• Device Sequence Number: 6211931
• Product Code: HIH
• UDI-Device Identifier: 00821925008205
• UDI-Public: 00821925008205
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/19/2024

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: REXEIS-HCF25
• Device Lot Number: RXJT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2023
• Supplement Date Received by Manufacturer: 12/20/2023; 01/18/2024
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 01/03/2024; 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2014
• 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