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

Model Number M3-30A

Device Problem Optical Problem (3001)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus and evaluated.The reported problem was confirmed and the cause assigned to light guide fiber breakage due to mishandling.

Event Description

A user facility reported to olympus that "light does not go through lens." there was no patient injury or harm associated with the problem reported to olympus.

Manufacturer Narrative

This supplemental report is being submitted to provide additional event related information.Updates to sections b5 and e2.

Event Description

The reported problem occurred during reprocessing.There was no report of delays in procedures due to the reported problem.

Manufacturer Narrative

This supplemental report is submitted to provide the result of a device history record (dhr) review.The dhr was reviewed for the subject device.No anomalies were noted and it was verified the device was manufactured in accordance with documented specifications and procedures.

Manufacturer Narrative

Upon further review, this is not a reportable malfunction.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

• 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: 10224304
• MDR Text Key: 198482421
• Report Number: 3003790304-2020-00046
• 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,Followup
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• 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: 05/30/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1