MAUDE Adverse Event Report: GYRUS ACMI, INC REX 6.9FR URETEROSCOPE, 33CM; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number REXMR-6A

Device Problem Sharp Edges (4013)

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

Event Date 06/28/2022

Event Type  malfunction  

Event Description

Customer reported with an issue of "rough place on end of shaft has burr".The issue found during reprocessing.There was no patient harm, no user injury reported due to the event.

Manufacturer Narrative

The subject device was received and evaluated.Device evaluation and inspection, service repair noted the following findings: the complaint of damaged distal end was confirmed.However, no sharp edge or burr was observed during device inspection.Evaluation and inspection findings include dents on distal end and debris in fiber system.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the device was manufactured.Based on the results of the investigation, it is likely that the reported phenomenon occurred due to improper handling during device reprocessing.A definitive root cause cannot be identified.The instructions for use (ifu) instruction manual state: ifu states as follows: ¿study this manual and other labeling thoroughly for safe handling and storage.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"; "do not use an instrument that fails to meet the criteria stated in the labeling or that has been damaged.¿ olympus will continue to monitor the field performance of this device.

• Brand Name: REX 6.9FR URETEROSCOPE, 33CM
• Type of Device: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): GYRUS ACMI, INC; 93 north pleasant st.; norwalk OH 44857
• Manufacturer Contact: todd brill ; 93 north pleasant st.; norwalk, OH 44857 ; 5082077661
• MDR Report Key: 15107042
• MDR Text Key: 304796438
• Report Number: 1519132-2022-00009
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 00821925007826
• UDI-Public: 00821925007826
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 08/24/2022

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: REXMR-6A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 07/26/2022
• Supplement Dates Manufacturer Received: 07/27/2022
• Supplement Dates FDA Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2020
• 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