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

Model Number	MR-6A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device was evaluated.Upon inspection of the returned subject device, the customer reported issue was confirmed.It was found that the outer tube at the distal tip was damaged through melting, leaving the tip with a sharp edge.Fiber breakage and blurry image were also observed.Device history records were reviewed and showed the product met all specifications upon release.Based on the device inspection results, damages that occurred to the device were most likely due to use mishandling.The device ifu (instruction for use) 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 and keep the distal tip of any electrode, probe, laser fiber or other ancillary device in the field of view at all times when active.Damage to the endoscope may occur from direct or reflected energy.Olympus will continue to monitor complaints for this device.
Event or Problem Description
It was reported that the scope is damaged.The issue found during an unknown event.There was no patient involvement reported due to the event.No user injury reported.Device return evaluation found the outer tube at the distal tip of the device was damaged with a sharp edges.

• Brand Name: URETEROSCOPE, 33CM
• Common Device Name: URETEROSCOPE, 33CM
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 12167743
• Report Number: 1519132-2021-00013
• Device Sequence Number: 11717466
• 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): 07/14/2021

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: 06/18/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1