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

Model Number	EIS-HCF25
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported with an issue of the "inner sheath damaged tip".The issue occurred during reprocessing.According to the report, the damage was noticed while reprocessing the item and was received in the department without any patient information or issues with the surgery.No further information was provided.No harm was reported.No patient harm, no user injury reported.
Additional Manufacturer Narrative
The subject device was received and evaluated.Device evaluation found the reported issue was confirmed.The sheath tip was broken, sharp, and deformed.No additional defects/failures were noted.Device history records (dhrs) were reviewed and showed the product met all specifications upon release.Manufacturing date: november 2018.The final manufacturing date was not provided in the dhrs.Based on the device inspection findings and the incident information provided , the damage which occurred was most likely due to user mishandling during device reprocessing.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) olympus will continue to monitor complaints for this device.

• Brand Name: CF RESECTOSCOPE INNER SHEATH, 25FR
• Common Device Name: RESECTOSCOPE
• 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: 16319736
• Report Number: 1519132-2023-00007
• Device Sequence Number: 15451985
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/08/2023

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: KB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 02/08/2023
• 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