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

Model Number M3-30A

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to the service center for evaluation; however, the device evaluation is still pending.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that the device was found with damaged outer tube.The edge was found cracked.No further details were provided regarding the event.No patient involvement on this reported event.No user harm or injury was reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the device return evaluation, review of the device history records (dhr).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.Olympus received the device and evaluation determined that the reported issue was not confirmed, however moisture underneath the cover glass and broken meniscus on the lens were observed.The moisture and the broken meniscus lens contributed to the foggy image.The found failures are known issues.System lens breakage often results from user mishandling.The device ifu provides warnings and cautions indicating that equipment may be damaged by misuse.Particularly, ¿misuse of instruments¿ can cause injury to the patient and could have an adverse effect on the procedure being performed.Do not drop instruments or allow them to be struck by other objects.Keep instruments separate from one another to avoid damage 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: 10515184
• MDR Text Key: 206551267
• Report Number: 1519132-2020-00068
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/14/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/18/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 10/09/2020
• Supplement Dates FDA Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1