MAUDE Adverse Event Report: GYRUS ACMI, INC URETEROSCOPE, 33CM; RIGID / SEMI RIGID SCOPES

Model Number MR-6A

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to the service center for evaluation.Upon inspection of the returned device, the user report was confirmed, finding the distal end was damaged and dented.Minor dents in e/p edge and slightly cloudy image were also noted.The investigation is ongoing.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that the device distal tip is damaged, broken with a sharp edge.There was no patient involvement reported on this event.No user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.Device history records were reviewed and showed the product met all specifications upon release.Based on device evaluation results, physical damage found on the device was most likely due to user mishandling.To avoid inadvertent damage, the device ifu advises: 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.

• Brand Name: URETEROSCOPE, 33CM
• Type of Device: RIGID / SEMI RIGID SCOPES
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11371822
• MDR Text Key: 244695000
• Report Number: 1519132-2021-00005
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 00821925006225
• UDI-Public: 00821925006225
• 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: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MR-6A
• Device Catalogue Number: MR-6A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1