MAUDE Adverse Event Report: GYRUS ACMI, INC M3-GOLD AUTOCLAVABLE LATERAL TELESCOPE 70 DEG; ADULT RESECTOSCOPE

Model Number M3-70A

Device Problem Poor Quality Image (1408)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the user facility report was confirmed.The evaluation results found no image due to fractured internal lenses.Additionally, there were dents on the outer tube.The user facility elected to have the device exchanged rather than serviced.Based on a review of manufacturing records (dhr review) the m3-70a with serial number (b)(4) was shipped as a replacement scope, manufactured feb.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.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 customer reported that the device was dropped and no image.There was no report of patient harm or involvement.There was no additional information provided.Olympus has made multiple attempts to gather additional information related to this report but with no results.

Manufacturer Narrative

The investigation has been completed.Based on the inspection findings, the most probable cause of the incident was caused by user mishandling of the device.The instructions for use (ifu) warnings state: ¿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.".

Manufacturer Narrative

Device history records for this product have been reviewed.The records indicate that the unit was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Based on the device inspection result, the physical damages to the device were most likely caused by user mishandling.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 LATERAL TELESCOPE 70 DEG
• Type of Device: ADULT RESECTOSCOPE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10543388
• MDR Text Key: 209166310
• Report Number: 1519132-2020-00073
• 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: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M3-70A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1