MAUDE Adverse Event Report: GYRUS ACMI, INC SLIMLINE URETEROSCOPE

Model Number MRO-742A

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was returned and evaluated.Evaluation determined that the reported failure was confirmed.The device was observed with a bent shaft.The defective device however was not repaired.Customer requested to have the scope returned unrepaired.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that the device was found with bent shaft.The reported issue occurred during reprocessing.There was no patient involvement on this report.No user harm or injury was reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the review of the device history records (dhr).Device evaluation on the device confirmed the user request.The root cause of the shaft being bent is most likely due to excessive force by the user.The image was also found to be blurry, most likely due to low transmitting light carrier fibers.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.As stated in the instructions for use as a preventive measure: 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.Olympus will continue to monitor complaints for this device.

• Brand Name: SLIMLINE URETEROSCOPE
• Type of Device: SLIMLINE URETEROSCOPE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10471709
• MDR Text Key: 204975111
• Report Number: 1519132-2020-00060
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• PMA/PMN Number: K011849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MRO-742A
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1