MAUDE Adverse Event Report: GYRUS ACMI, INC GYN OPERATIVE 12 DEGREE 2.7MM LONG AUTOCLAVABLE; RIGID CULDOSCOPE AND ACCESSORIES

Model Number G27L-12A

Device Problems Material Separation (1562); Component Missing (2306)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 06/08/2020

Event Type  malfunction  

Manufacturer Narrative

There is no additional information for this event as yet.The device is not returned, as such a definitive root cause of the reported complaint cannot be determined at this time.Supplemental report(s) will be filed as the information becomes available.

Event Description

As reported for this event, the device locking pin had fallen out and the sheath cannot be connected.There is no patient involvement.

Manufacturer Narrative

Relevant additional information has been received for this event.This information is being provided in this supplemental report.Please see the updates in sections: a3, g4, g7, h2, h6, and h10.The event took place during the beginning of a diagnostic hysteroscopy procedure.The locking pin for the device telescope was missing and the sheath could not be connected.The missing locking pin was not found.The procedure was delayed by 10 minutes and was completed with another similar device.There was no adverse impact to the patient.

Manufacturer Narrative

Device has been returned and device evaluation completed for it.This supplemental report is being submitted to provide this information.This device was manufactured in august 2015.The device history record review did not find any defects, nonconforming issue or any corrective action issues during the assembly build of the device.All records indicate the device was manufactured in accordance with all applicable procedures and final product release criteria.User complaint of missing pin was confirmed.Upon inspection, it was noted that the direction pin was missing.Incidental observations were debris underneath cover glass on eye cup affecting the image and some damage on the distal end.

Manufacturer Narrative

There is additional information for this event.This supplemental report is being submitted to provide this information.Device history records did not include packaging or labeling operations for this reason the udi is not available.Base on the user facility report, there was no patient injury or harm.This led to the conclusion, the pin must have fallen outside of the patient's body, therefore did not caused the patient to experience any immune response to foreign body object, and infection.The most likely root cause was user mishandling leading to the disengagement of the locking pin.

• Brand Name: GYN OPERATIVE 12 DEGREE 2.7MM LONG AUTOCLAVABLE
• Type of Device: RIGID CULDOSCOPE AND ACCESSORIES
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10214868
• MDR Text Key: 198701801
• Report Number: 1519132-2020-00024
• 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,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: G27L-12A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1