MAUDE Adverse Event Report: GYRUS ACMI, INC URETEROSCOPE, 33CM

Model Number MR-6A

Device Problem Sharp Edges (4013)

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

Event Type  malfunction  

Manufacturer Narrative

The physical evaluation found that the distal end of the outer tube was dented and sharp.In addition, the reported "poor visibility" was confirmed and was likely due to moisture in the optical system.Also there were dents in the objective window and fiber breakage were also observed at the distal end.The legal manufacturer performed the device history records for this device.The scope was a repair exchange and was manufactured on august 14, 2020.All records show the product met all specifications upon release.Based on the results of device inspection, the root cause of the reported failure is most likely due to user mishandling.As stated on the ifu (instruction for use) and as a preventive measure, the user manual states: "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." (warnings, page 4).Olympus will continue to monitor complaints for this device.

Event Description

The service center was informed that a customer ureteroscope, 33cm was returned due to a report of "poor visibility".Upon inspection and testing, the distal end of the outer tube was observed to be dented and sharp.No patient harm or involvement was reported to olympus.

• Brand Name: URETEROSCOPE, 33CM
• Type of Device: URETEROSCOPE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 12041313
• MDR Text Key: 281348619
• Report Number: 1519132-2021-00011
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 00821925007826
• UDI-Public: 00821925007826
• Combination Product (y/n): N
• PMA/PMN Number: K052044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 06/22/2021

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: MR-6A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/01/2021
• Initial Date FDA Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1