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

Model Number M3-30A

Device Problems Break (1069); Defective Device (2588)

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 during receipt inspection, the device was found with damage distal tip and the lens were cracked.There was no patient involvement on this report.No user harm or injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide updates on lot number.Per oem (original equipment manufacturers confirmation, the correct serial # is (b)(6) not (b)(6).

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.Device evaluation revealed internal lenses were found to be broken.The e/p widow cover glass was also found to be chipped.Moisture inside the objective lens and a minor chip on the objective lens were observed.The image on the telescope had a severe blur and shadow stain, which could be attributed to broken system lens, chipped cover glass, and moisture.A definitive root cause of the reported complaint cannot be determined at this time.The physical damages to the device were likely contributed to rough handling during transportation.However, moisture found inside the objective lens suggests there might be other factors contributing to the observed failures.As stated on the ifu (instruction for use) and as a preventive measure, the user manual states: upon receipt, examine the instrument and accessories for damage.Do not use a damaged product.To ensure satisfactory performance, perform the prescribed inspections and operational tests as recommended.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: 10576671
• MDR Text Key: 208386027
• Report Number: 1519132-2020-00076
• 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,Followup
• Report Date: 11/25/2020

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
• Device Lot Number: 787943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/27/2020
• Initial Date FDA Received: 09/23/2020
• Supplement Dates Manufacturer Received: 11/02/2020; 11/02/2020
• Supplement Dates FDA Received: 11/25/2020; 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1