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

Model Number	REXEIS-HCF25
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The damaged device was not returned to the service center for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available at a later time, this report will be supplemented accordingly.This type of tip damage is most likely due to impact or handling of the device.The instruction manual warns users to "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.
Event or Problem Description
The service center was informed that at the conclusion of a therapeutic procedure, the black distal tip of the inner sheath cracked into two pieces and fell inside the patient.The broken pieces were retrieved from the patient¿s bladder.The intended procedure was completed.There was no patient injury reported.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information.Please see the updates in sections: g4, g7, h2, h6 and h10.Additional information from the user facility states there was a 3 to 5 minute delay in the procedure while the patient was under general anesthesia.There was no medical intervention or patient injury associated with this issue.There were no other devices replaced during the procedure.Additionally, the device was inspected prior to use and no anomalies were observed.At the time of the event, the doctor was retrieving ¿chips¿ of tissue with the loop electrode.No cautery was used at this point.The doctor saw the tip break off into the bladder and went back in with grasping forceps to retrieve.There were no error messages or alert tones associated with this event.The dhr review of the eis-hcf25 serial/lot number mb was shipped, manufactured november 2018, did not find any defects, nonconforming issue or any corrective action issues during the assembly build of the device.All records indicate the device was manufactured in accordance with all applicable procedures and final product release criteria.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information received.Upon further review, this is not a reportable malfunction.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.
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.Correction to g3 of the initial medwatch.The aware date should be 12-jun-2020.Correction has been that this event has been determined to be reportable.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Based on the results of the investigation, it is likely the cause of the malfunction is stress from mishandling.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: CF RESECTOSCOPE INNER SHEATH, 25FR
• Common Device Name: CF RESECTOSCOPE INNER SHEATH
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: kenneth pittman ; 93 north pleasant st.; norwalk, OH 44857 ; 9013785969
• MDR Report Key: 10262329
• Report Number: 1519132-2020-00028
• Device Sequence Number: 16730664
• Product Code: HIH
• UDI-Device Identifier: 00821925008205
• UDI-Public: 00821925008205
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/08/2022

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-HCF25
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/12/2020
• Supplement Date Received by Manufacturer: 07/28/2020; 03/23/2021; 05/18/2022; 05/18/2022
• Initial Report FDA Received Date: 07/12/2020
• Supplement Report FDA Received Date: 08/27/2020; 04/02/2021; 06/01/2022; 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2016
• 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