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

Model Number G27L-12A

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.The customer did not want to proceed with exchange, and repair.Due to no device return, the reported complaint was not confirmed, and a possible cause of the reported failure cannot be determined at this time.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 will continue to monitor complaints for this device.

Event Description

It was reported that the device adapter was found to be broken.There was no patient involvement on this event.No user injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide trend analysis and investigation conclusion.Device history records (dhr) for this product could not be located as the scope was manufactured in october 2005.However, according to-process inspection and final inspection the device had to pass in-process and final inspections prior to being release to distribution.Due to no device return, the reported complaint was not confirmed, and a possible cause of the reported failure cannot be determined at this time.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: 11050433
• MDR Text Key: 223455511
• Report Number: 1519132-2020-00109
• 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: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1