MAUDE Adverse Event Report: GYRUS ACMI, INC. REPAIR-EXCHANGE, USA ELITE CFR INNER SHEATH, 27FR

Model Number	REXEIS-CFR-27
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 insulation tip was broken off and missing.In addition, the plastic release button from the lock ring and the red dot from shoulder screw were missing.No issues with device passage and locking mechanism were found.The dhr was unable to be reviewed for this device.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the damage which occurred was most likely due to improper handling during.A definitive root cause cannot be identified.This information is addressed in the instructions for use (ifu): "study this manual and other labeling thoroughly for safe handling, storage and usage, including instructions for all generators and accessories.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." (warnings , page 4) olympus will continue to monitor the field performance of this device.
Event or Problem Description
The customer reported to olympus that the ceramic tip has broken off.The reported problem was found during reprocessing.There was no harm or user injury reported due to the event.

• Brand Name: REPAIR-EXCHANGE, USA ELITE CFR INNER SHEATH, 27FR
• Common Device Name: SHEATH
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15406887
• Report Number: 3003790304-2022-00234
• Device Sequence Number: 6840007
• Product Code: FAS
• UDI-Device Identifier: 00821925008199
• UDI-Public: 00821925008199
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 09/12/2022

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: REXEIS-CFR-27
• Device Lot Number: RXKD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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