MAUDE Adverse Event Report: GYRUS ACMI, INC M3-GOLD AUTOCLAVABLE FOROBLIQUE TELESCOPE 30 DEG; HYSTEROSCOPE (AND ACCESSORIES)

Model Number M3-30A

Device Problem Poor Quality Image (1408)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The suspect device was returned to olympus and evaluated.The reported problem was confirmed and the cause assigned to a fractured lens.In addition, excessive debris was found underneath the cover glass on the eye cup, the outer tube was found bent and the meniscus was noted out of place, causing debris.Based on the results of the device evaluation, the likely cause of the damaged condition of the device and excessive debris is user mishandling.The device history record for the subject scope was reviewed.All records indicate the device was manufactured in accordance with all applicable procedures and final product release criteria.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 user facility reported to olympus the device had a "blurry" image.The device problem was reported to be observed prior to the start of a diagnostic procedure.The intended procedure was completed using another device (details unknown).There was no patient injury or harm, associated with the problem, reported to olympus.

Manufacturer Narrative

This supplemental report is submitted to provide the results of the legal manufacturer¿s investigation and device history record (dhr) review.A dhr review was performed for the subject device.All records indicate the device was manufactured in accordance with all applicable procedures and final product release criteria.The legal manufacturer performed an investigation.The likely cause was confirmed as user handling during device reprocessing.The device ifu provides warnings and cautions to alert that the device may be damaged by improper handling.It 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.".

• Brand Name: M3-GOLD AUTOCLAVABLE FOROBLIQUE TELESCOPE 30 DEG
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10377039
• MDR Text Key: 205982654
• Report Number: 1519132-2020-00045
• 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: 10/26/2020

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: Health Professional
• Device Model Number: M3-30A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/18/2020
• Initial Date FDA Received: 08/06/2020
• Supplement Dates Manufacturer Received: 10/26/2020
• Supplement Dates FDA Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1