MAUDE Adverse Event Report: GYRUS ACMI, INC M3-GOLD AUTOCLAVABLE FOROBLIQUE TELESCOPE 30 DEG; ADULT RESECTOSCOPE

Model Number M3-30A

Device Problem Poor Quality Image (1408)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was evaluated by olympus and the user facility report was confirmed and evaluation results found a fractured lens.Additional findings were bent outer tube, damage on the objective window and moisture underneath the cover glass on the eye cup.The dhr review of the m3-30a serial number (b)(4) was shipped as an replacement device, manufactured july 2017, did not find any defects, nonconforming issue or any corrective action issues during the assembly build of the device.All records indicate the device was manufactured in accordance with all applicable procedures and final product release criteria.An investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.The root cause is suspected to be mishandling of the product based off the physical evaluation.Olympus will continue to monitor complaints for this device.This mdr is being submitted retrospectively as part of a remediation effort related to recent system and process changes.A capa has been opened to manage the actions related to remediation of this issue and any required mdr reporting.

Event Description

The user facility reported the device is providing a cloudy image.No report of patient injury and no patient involvement.

Manufacturer Narrative

This supplemental report is submitted to correct fields d4 and h4.

Manufacturer Narrative

This supplemental report is submitted to correct the serial number.Field d4 updated.

• Brand Name: M3-GOLD AUTOCLAVABLE FOROBLIQUE TELESCOPE 30 DEG
• Type of Device: ADULT RESECTOSCOPE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10538633
• MDR Text Key: 209166753
• Report Number: 1519132-2020-00072
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• PMA/PMN Number: K890328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 11/11/2020

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: Other
• Device Model Number: M3-30A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/18/2020
• Initial Date FDA Received: 09/15/2020
• Supplement Dates Manufacturer Received: 10/26/2020; 10/29/2020
• Supplement Dates FDA Received: 11/10/2020; 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1