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

Model Number ERIS-CF25

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The customer reported to olympus that the device tip had broken off.The reported problem was found during reprocessing.There was no patient involvement reported.

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 found to be damaged and broken off.There were no issues with the sheath passage and locking.The red dot from shoulder screw and proximal housing was missing.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported issue.Dhrs provided do not include packaging or labeling operations.For this reason the final manufacture date is approximately may 2010.Based on the results of the investigation, it is likely that the issue was due to device design.In march 2014, to remediate tip fracture, a design change in material and geometries of the tips has been implemented.The new tip material has been successfully validated for production release.This complaint device has an old designed tip as it was produced in may 2010, before corrective actions were taken.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.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 the field performance of this device.

• Brand Name: ROTATING CF RESECTOSCOPE INNER SHEATH
• Type of Device: RESECTOSCOPE
• 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: 15147395
• MDR Text Key: 304909617
• Report Number: 3003790304-2022-00135
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ERIS-CF25
• Device Lot Number: FO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1