MAUDE Adverse Event Report: GYRUS ACMI, INC. NON-CF RESECTOSCOPE METAL SHEATH, 24 FR; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number	EMRS-24
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
A user facility reported that the distal tip of a scope was broken.It is unknown when the reported issue occurred.There was no patient injury or adverse event reported to olympus.
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.During the evaluation, the complaint was confirmed.It was found that the insulating tip was chipped and damaged.In addition, meatus washer was broken off and damaged, and the red dot on the sheath head was missing.A review of the device history record found no deviations that could have caused or contributed to the reported issue.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.

• Brand Name: NON-CF RESECTOSCOPE METAL SHEATH, 24 FR
• Common Device Name: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): GYRUS ACMI, INC.; 93 north pleasant st.; norwalk OH 44857
• Manufacturer (Section G): GYRUS ACMI INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 93 north pleasant st.; norwalk, OH 44857 ; 5082077661
• MDR Report Key: 15123177
• Report Number: 1519132-2022-00012
• Device Sequence Number: 7381949
• Product Code: FAS
• UDI-Device Identifier: 00821925001961
• UDI-Public: 00821925001961
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/28/2022

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: EMRS-24
• Device Lot Number: HW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2006
• 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