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

Model Number	MR-6A
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: URETEROSCOPE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 12041313
• Report Number: 1519132-2021-00011
• Device Sequence Number: 14502818
• Product Code: FGB
• UDI-Device Identifier: 00821925007826
• UDI-Public: 00821925007826
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K052044
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1