MAUDE Adverse Event Report: GYRUS ACMI L.P. CF RESECTOSCOPE INNER SHEATH, 25FR

Model Number	EIS-HCF25
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and evaluated, and the customer¿s allegation was confirmed; the beak was broken with missing segments, and the metal sheath tube was cracked and dented at the proximal end connecting with the locking mechanism.Additionally, ¿22f¿ was printed on the sheath tube; this is not a valid product lot number (as confirmed by the original equipment manufacturer's instructions), thus the device was believed to have been previously repaired by a third party distributor.The following information is documented based on the legal manufacturer's investigation.Based on the device inspection findings and the incident information provided , the reported failure was most likely due to user mishandling during device reprocessing.Ceramic tip facture had been addressed by the oem.In march 2014, to remediate tip fracture, a design change in material and geometries of the tips has been implemented.The new tip material has been successfully validated for production release.As the lot number of the complaint is unknown, it is unknown if the device has an old or newly designed ceramic tip.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 ifu (instructions for use, rev 99-1033_fk).The ifu states, "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." (warnings#1, page 4); " 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." (warnings#3, page 4).As a risk assessment performed by product quality engineer, there will be no further actions taken in response to this complaint since olympus has taken the corrective actions to minimize the occurrence of tip fracture, and the occurrence of sheath tip fracture is within the expected values from the dfmea for both the family and the specific model.Olympus will continue to monitor the field performance of this device.A supplemental report will be filed if any additional information provided by the user facility.
Event or Problem Description
The customer reported to olympus that there was a damaged tip on the cf resectoscope inner sheath (25fr).The issue occurred during reprocessing, and there was no patient harm or procedural impact associated with the event.The device was returned and evaluated, and the beak was broken with missing segments, and the metal sheath tube was cracked and dented at the proximal end connecting with the locking mechanism.This mdr is being submitted to capture the reportable malfunction found during the device evaluation.
Additional Manufacturer Narrative
This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is (b)(4).

• Brand Name: CF RESECTOSCOPE INNER SHEATH, 25FR
• Common Device Name: RESECTOSCOPE
• Manufacturer (Section D): GYRUS ACMI L.P.; 9600 louisiana avenue north; suite 102; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI L.P.; 9600 louisiana avenue north; suite 102; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16378031
• Report Number: 3003696010-2023-00001
• Device Sequence Number: 12357744
• Product Code: FAS
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2024

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: EIS-HCF25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2023
• 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: 01/20/2023
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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