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

Model Number G27L-30WA

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was received and evaluated.Evaluation determined that the reported failure was not able to be duplicated however, it was observed that the device was found overhauled.The root cause of the reported event cannot be determined and is unknown.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that the device failed the leak test.The issue occurred during reprocessing.There was no patient involvement on this report.No user harm or injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the 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.The root cause of the reported issue was not identified.Device evaluation was unable to confirm the reported leak issue.However, the device was found to be overhauled and had no image.The root cause of image loss could not be determined.As stated on the ifu (instruction for use) and as a preventive measure, the user manual states : study this manual and other labeling thoroughly for safe handling and storage.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.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: 10645376
• MDR Text Key: 223445981
• Report Number: 1519132-2020-00086
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• 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: 09/14/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1