MAUDE Adverse Event Report: GYRUS ACMI, INC 2.7MM LONG GYN TELESCOPE

Model Number G27L-30WA

Device Problem Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was received and evaluated.Evaluation determined that the device screw piece was found damaged.Severe debris was found under the funnel cup e/p window cover glass and stains were observed on the image.Device was placed for repair.If additional information becomes available this report will be supplemented accordingly.Root cause of the reported issue is unknown.Likely probable cause could be due to users handling of the device and or maintenance issue.

Event Description

It was reported that the device screw piece was found damaged.No further details provided regarding the event.There was no patient involvement reported, no user harm or injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide review of the device history records (dhr) and investigation conclusion.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.During the device evaluation as stated on the initial report, severe debris was found under the e/p window glass cover and stains on the image were observed.The debris that caused the stained image possibly migrated into the field of view during use or maintenance.As stated on the instruction for use as a preventive measure: upon receipt, examine the instrument and accessories for damage.Do not use a damaged product, and to ensure satisfactory performance, perform the prescribed inspections and operational tests as recommended.Olympus will continue to monitor complaints for this device.

• Brand Name: 2.7MM LONG GYN TELESCOPE
• Type of Device: 2.7MM LONG GYN TELESCOPE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10605928
• MDR Text Key: 209165055
• Report Number: 1519132-2020-00081
• Device Sequence Number: 1
• Product Code: HEW
• Combination Product (y/n): N
• PMA/PMN Number: K980972
• 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: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G27L-30WA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1