MAUDE Adverse Event Report: GYRUS ACMI, INC GYN OPERATIVE 12 DEGREE 2.7MM LONG AUTOCLAVABLE

Model Number G27L-12A

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was received for evaluation.Evaluation determined that the outer tube of the device was found bent, and with dent.Funnel cup was found with a crack, and device was found with black image.The identified parts needs to be replaced.The device was placed for repair.Based on evaluation findings, the root cause of the reported issue is unknown.Likely probable cause can be due to users mishandling of the device.This mdr is being submitted retrospectively as part of a remediation effort related to the recent system, and process changes.A capa has been opened to manage the actions related to remediation of this issue, and any required reporting.

Event Description

It was reported that the device was found with cloudy lens, and cracked on the eyepiece.The issue occurred during reprocessing.There was no patient involvement on this event.No user harm or injury was reported.

Manufacturer Narrative

This supplemental report is being submitted to provide 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.The reported event occurred during reprocessing, physical damages found to the device were most likely due to user mishandling 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.Do not loosen or remove the instrument eyepiece; damage and fluid leakage can result.Olympus will continue to monitor complaints for this device.

• Brand Name: GYN OPERATIVE 12 DEGREE 2.7MM LONG AUTOCLAVABLE
• Type of Device: GYN OPERATIVE 12 DEGREE 2.7MM LONG AUTOCLAVABLE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10576748
• MDR Text Key: 208777744
• Report Number: 1519132-2020-00078
• 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,foreig
• 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: 09/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G27L-12A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1