MAUDE Adverse Event Report: GYRUS ACMI, INC URETEROSCOPE, 43CM

Model Number MR-6LA

Device Problems Break (1069); Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device evaluation confirmed the reported failure.The distal tip was bent with knurled ring received.Image was out of center due to bent distal tube.Minor debris under e/p window was noted.Dhrs (device history records) for this product has been reviewed.The device was an rex scope manufactured on may 01, 2019.All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Bent distal tip is a known phenomenon that is often incurred as a result of user mishandling.On page 8 of the device ifu (instruction for use), bent shaft is addressed, "undue stress on the endoscope shaft may cause bending or breaking.If the distal shaft is bent due to the rigors of a difficult procedure, do not attempt to straighten it; damage can result." the iuf advises: "avoid using excessive torque/force on the endoscope, as patient injury and possible damage to the instrument could result.Olympus will continue to monitor complaints for this device.

Event Description

It was reported that the device distal tip was found bent, damaged, broken with a sharp edge.There were no further details provided regarding the reported event.No patient involvement reported.No user injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide customer updates and response.Please see updated sections: e1, e2, e3, g4, g7, h2, h6 and h10.Further communication with the customer conveyed the following information: the issue occurred during the procedure.The procedure was diagnostic.The name of the procedure was unable to be provided.There were no other devices involved in the event.There was no delay in the procedure.The intended procedure was able to be completed.The same device was not used to complete the procedure.The model, serial/lot # of the device used to complete the procedure was unable to be provided.The device failed at the end of the procedure.The patient demographics are unknown.There were no other devices replaced during the procedure.The information in regards to the device being returned was unable to be provided.The date the event occurred on is unknown.There were kinks in the device at the end of the procedure.A leak test is being performed after each use of the scope.The device is reprocessed in a vpro.There was no metal protruding.The bending section was broken and the rubber was kinked.It is unknown how the distal tip became damaged or bent.

• Brand Name: URETEROSCOPE, 43CM
• Type of Device: URETEROSCOPE, 43CM
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11095822
• MDR Text Key: 225522701
• Report Number: 1519132-2020-00110
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 00821925007833
• UDI-Public: (01)00821925007833
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 01/28/2021

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-6LA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 01/15/2021
• Supplement Dates FDA Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1