MAUDE Adverse Event Report: GYRUS ACMI, INC. URETEROSCOPE, 43CM; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number MR-6LA

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2024

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus that the ureteroscope, 43cm had no image and the tip was cracked.The event occurred during reprocessing.There was no patient harm associated with the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on corrected information.The following fields were updated accordingly: d4.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.D9, h3, and h6 have also been updated.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely that the physical damage observed on the device resulted from improper handling.However, the root cause of the events could not be determined.The suggested event is detectable and preventable by handling the scope in accordance with the following sections of the instructions for use: the device ifu (instruction for use_99-1088_ff) 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." (page 4); "pay close attention to the care, cleaning, disinfection, and sterilization instructions in this manual.Any deviation can cause damage." (page5).Olympus will continue to monitor the field performance of this device.

• Brand Name: URETEROSCOPE, 43CM
• Type of Device: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): GYRUS ACMI, INC.; 93 north pleasant st.; norwalk OH 44857
• Manufacturer (Section G): GYRUS ACMI, INC.; 93 north pleasant st.; norwalk OH 44857
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18572179
• MDR Text Key: 333615083
• Report Number: 1519132-2024-00001
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/20/2024

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/08/2024
• Initial Date FDA Received: 01/24/2024
• Supplement Dates Manufacturer Received: 02/06/2024; 02/06/2024
• Supplement Dates FDA Received: 02/12/2024; 02/20/2024
• 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