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

Model Number M3-30A

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.During the evaluation the reported issue was confirmed.The cloudy image was due to moisture.The outer tube was found bent.The objective window was visually inspected and a damaged distal end was observed.There was moisture underneath the cover glass on the distal tip.Moisture was also observed underneath the cover glass on the eye cup.A review of the device history record (dhr) did not find any defects or nonconforming issues related to the assembly build of the device.The device was manufactured in accordance with all applicable procedures.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

A surgical technician from a user facility reported that the lens was black and that it looked like it had blown out.It was reported that the procedure was completed using a similar device.No patient harm was reported.No additional information was provided.

Manufacturer Narrative

This supplemental report is being submitted to correct the serial number and the unique device identifier (udi) provided in the initial report and to provide an update to the device investigation.The results of the device history record review remain unchanged.The root cause of the physical damage was likely user mishandling along with excessive force being applied to the device.The ifu contains the following statement: "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." olympus will continue to monitor for similar events.

• 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: 10440027
• MDR Text Key: 204026315
• Report Number: 3003790304-2020-00073
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/31/2021

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: M3-30A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/17/2020
• Initial Date FDA Received: 08/21/2020
• Supplement Dates Manufacturer Received: 03/26/2021
• Supplement Dates FDA Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1