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	12/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.The device was returned to olympus for evaluation where service confirmed the customer's complaint.The tip was broken off and damaged, and the red dot on shoulder screw was missing.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported issue.The provided dhrs do not include packaging or labeling operations.For this reason, a final manufacture date is june 2019.Based on the results of the investigation, a definitive root cause cannot be identified.This information is addressed in the instructions for use (ifu): "warning: always keep sheaths parallel to one another when assembling and disassembling.If the inner sheath is inserted or removed at an angle to the outer sheath, the lateral force applied to the inner sheath may crack, loosen, break, or otherwise damage the sheath¿s insulated distal tip.A broken tip, or fragments of a damaged tip, can potentially pass through the outer sheath and into the patient.If drag or resistance is encountered during assembly or disassembly, stop¿align working element and sheath parallel to one another before proceeding." olympus will continue to monitor the field performance of this device.
Event or Problem Description
The customer reported to olympus that the ceramic tip broke in to multiple pieces.The reported problem was found during an unspecified procedure.There was no harm or user injury reported due to the event.

• Brand Name: CF RESECTOSCOPE INNER SHEATH, 25FR
• Common Device Name: SHEATH
• Manufacturer (Section D): 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: 15160268
• Report Number: 3003790304-2022-00144
• Device Sequence Number: 6167338
• Product Code: FAS
• UDI-Device Identifier: 00821925001893
• UDI-Public: 00821925001893
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/03/2022

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: GC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2021
• Initial Report FDA Received Date: 08/03/2022
• 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