MAUDE Adverse Event Report: GYRUS ACMI, INC M3-GOLD AUTOCLAVABLE LATERAL TELESCOPE 70 DEG; HYSTEROSCOPE (AND ACCESSORIES)

Model Number M3-70A

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 observed it was due loose lens and debris.The meniscus was out of place causing debris.The root cause cannot be determined.Olympus will continue to monitor the field performance of this device.Dhr review was performed and no non-conformances that would cause the reported malfunction were noted.No further information was reported.No further information was reported.

Event Description

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

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 LATERAL TELESCOPE 70 DEG
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10429019
• MDR Text Key: 208336045
• Report Number: 1519132-2020-00054
• 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

• 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: 04/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/30/2020
• Initial Date FDA Received: 08/19/2020
• Supplement Dates Manufacturer Received: 03/21/2021
• Supplement Dates FDA Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1