MAUDE Adverse Event Report: GYRUS ACMI, INC M3-GOLD AUTOCLAVABLE FOROBLIQUE TELESCOPE 30 DEG

Model Number M3-30A

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet been received for evaluation.The cause of the issue cannot be determined at this time.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that during receipt inspection, the device was found with a cracked lens.No further information provided regarding the event.There was no patient involvement on this report.No user harm or injury was reported due to the event.

Manufacturer Narrative

This supplemental report is being submitted to provide the device return evaluation, review of the device history records (dhr).Olympus received the device and evaluation determined that the reported issue was confirmed.The internal lenses were observed to be fractured, and e/p window cover glass was found chipped.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Therefore, it is very unlikely that manufacturing process contributed to the reported event.Furthermore, as the event was found during receipt inspection, the physical damages to the device was most likely due to rough handling during transportation.As stated on the ifu and as a preventive measure, the user manual states: upon receipt, examine the instrument and accessories for damage.Do not use a damaged product.Olympus will continue to monitor complaints for this device.

• Brand Name: M3-GOLD AUTOCLAVABLE FOROBLIQUE TELESCOPE 30 DEG
• Type of Device: M3-GOLD AUTOCLAVABLE FOROBLIQUE TELESCOPE 30 DEG
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10493929
• MDR Text Key: 209167065
• Report Number: 1519132-2020-00066
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/19/2020

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: M3-30A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/14/2020
• Initial Date FDA Received: 09/04/2020
• Supplement Dates Manufacturer Received: 10/19/2020
• Supplement Dates FDA Received: 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1