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

Model Number ERIS-CF25

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

There is no additional information available for this event.Event date is not known.Supplemental report(s) will be filed as the information becomes available.The device has been returned and a device evaluation completed for it.The device manufacture date is not known.The user¿s complaint was confirmed.Upon inspection, it was observed that the beak of the device was cracked and the tip broken off.The cause of this issue could not be determined.

Event Description

As reported for this event, during reprocessing the device ceramic tip was broken.There was no patient involvement.

Manufacturer Narrative

There is more information on the device evaluation.This supplemental report is being submitted to provide this information.Please see the updates in sections: g4, g7, h2, h6, and h10.The device was manufactured in september 2019.The device history review (dhr ) 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.

Manufacturer Narrative

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.

Manufacturer Narrative

Correction to g3 of the initial medwatch.The aware date should be 03-jun-2020.Correction has been that this event has been determined to be reportable.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.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 august 2019.Based on the results of the investigation, the reported failure was most likely due to user mishandling during device reprocessing, such as impact/dropped.A definitive root cause cannot be identified.Olympus will continue to monitor the field performance of this device.

• Brand Name: ROTATING CF RESECTOSCOPE INNER SHEATH
• Type of Device: ROTATING 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: 10201589
• MDR Text Key: 200630376
• Report Number: 1519132-2020-00023
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/22/2022

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
• Device Operator: Health Professional
• Device Model Number: ERIS-CF25
• Device Lot Number: IC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/03/2020
• Initial Date FDA Received: 06/26/2020
• Supplement Dates Manufacturer Received: 07/21/2020; 03/22/2021; 07/29/2022
• Supplement Dates FDA Received: 08/11/2020; 03/23/2021; 08/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1