MAUDE Adverse Event Report: GYRUS ACMI, INC SLIMLINE URETEROSCOPE; URETERO-RENO VIDEOSCOPE

Model Number MRO-742A

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

A visual inspection on the device found the shaft broken off from the main body of the device at the proximal end.The metal section on the broken end of the shaft is twisted, which would suggest that excessive force was used to cause the shaft to become detached/broken.The instruction manual states the following; ¿do not twist or bend the bending section with your hands.Equipment damage may result¿.The instructions for safe use manual also indicates that, damage to the bending section would happen if excessive force was applied while angulating in the opposite direction if there was no movement from the bending section; this would occur more so in a narrow environment.Additionally, the image seen through the eyepiece lens is very unclear, which would also likely be attributed from the damaged shaft.Based on the evaluation, the likely cause of the damaged and broken shaft is due to mishandling in the form of excessive force.

Event Description

It was reported that the scope has separated from the handle from the actual scope.A part of the scope is broken.

• Brand Name: SLIMLINE URETEROSCOPE
• Type of Device: URETERO-RENO VIDEOSCOPE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: kenneth pittman ; 93 north pleasant st.; norwalk, OH 44857 ; 9013785969
• MDR Report Key: 10140865
• MDR Text Key: 217367361
• Report Number: 1519132-2020-00015
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MRO-742A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1