MAUDE Adverse Event Report: GYRUS ACMI, INC ACCESSORY WORKING ELEMENT; HYSTEROSCOPE (AND ACCESSORIES)

Model Number EAWE

Device Problem Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 07/07/2020

Event Type  malfunction  

Manufacturer Narrative

Additional details of the event are not available 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 would not engage with the scope.There was no patient involvement.

Manufacturer Narrative

Upon further review this is not a reportable malfunction.Per the legal manufacturer there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.Please see the updates in sections: g4, g7, h2, and h10.

• Brand Name: ACCESSORY WORKING ELEMENT
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10341755
• MDR Text Key: 205012170
• Report Number: 1519132-2020-00034
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• PMA/PMN Number: K890328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: EAWE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/07/2020
• Initial Date FDA Received: 07/29/2020
• Supplement Dates Manufacturer Received: 08/25/2020
• Supplement Dates FDA Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1