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

Device has been returned for evaluation.The customer¿s complaint of cloudy image was confirmed.It was confirmed that the cloudy image was due to loose lens and debris.The meniscus was touching the cover glass causing excessive debris causing image issue.The cause could not be determined.No further information was reported.A review of the device history record was completed and it was confirmed that there were no abnormalities, special adoptions, or variations in the manufacturing process.

Event Description

The customer reported to olympus that the device's image was cloudy.There was no patient injury reported.

Manufacturer Narrative

This is a supplemental report to correct the initial mdr.The following sections were updated; g3, g6, h2, h10.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: 10429062
• MDR Text Key: 208335901
• Report Number: 1519132-2020-00053
• 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
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• 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: 04/29/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1