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

Model Number M3-70A

Device Problem Poor Quality Image (1408)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the service center for evaluation.The outer tube of the device was found bent and dented.Breakage was found on the device¿s e/p window unit and funnel cup.The optical fiber system was inspected and found the image blurry and foggy.The device was repaired and returned to the customer.

Event Description

The service center was informed that during reprocessing the device lens was noted to be speckled.There was no report of patient involvement.

Manufacturer Narrative

The dhr review of the m3-70a serial/lot number (b)(6) was shipped as an rex scope,manufactured january 2018, 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.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The legal manufacturer reviewed the contents of this complaint.The dhr review of the m3-70a serial/lot number (b)(6) was shipped as an rex scope, manufactured january 2018, 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.Based on the device evaluation results, the bend in the outer tube could result from an excessive force being applied or a strong impact having occurred to the device.This event can be preventable in accordance with instructions for use.The device ifu advises "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: M3-GOLD AUTOCLAVABLE LATERAL
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10153983
• MDR Text Key: 195128261
• Report Number: 1519132-2020-00017
• 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: user facility
• 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: Health Professional
• Device Model Number: M3-70A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/19/2020
• Initial Date FDA Received: 06/15/2020
• Supplement Dates Manufacturer Received: 08/19/2020; 10/29/2020
• Supplement Dates FDA Received: 09/13/2020; 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1