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

Model Number M3-30A

Device Problems Break (1069); Image Display Error/Artifact (1304); Optical Problem (3001)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Due diligence was executed for this event.Event date is not known.The device is not returned, as such a definitive root cause of the reported complaint cannot be determined at this time.Supplemental report(s) will be filed as the information becomes available.

Event Description

As reported for this event, during preparation for us, a chip was observed at the distal tip of the device.There is no patient involvement.The setup was done with another similar device without any delay.Intended procedure was completed.No other devices needed to be replaced.

Manufacturer Narrative

The device has been returned and a device evaluation completed for it.The user complaint of chip on the distal end is confirmed.This supplemental report is being submitted to provide this information.The device history record review 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.Device was manufactured in may 2018.The user complaint of chip on the distal end is confirmed.Upon inspection broken cover glass was observed; there was broken meniscus causing debris.Moisture underneath cover glass on distal tip was also noted.In addition it was noted that the debris underneath cover glass on eye cup was affecting image.

• 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: 10361901
• MDR Text Key: 203871486
• Report Number: 1519132-2020-00042
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/28/2020

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: No Information
• Device Model Number: M3-30A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/10/2020
• Initial Date FDA Received: 08/04/2020
• Supplement Dates Manufacturer Received: 09/03/2020
• Supplement Dates FDA Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1