MAUDE Adverse Event Report: AQUAMANTYS BIPOAR DISPOSABLE HAND PIECE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 10/02/2020

Event Type  malfunction  

Event Description

Aquamantys bipolar disposable hand piece not working intra-op, irrigation working but not sealing.Hand piece changed out.New hand piece working.Fda safety report id # (b)(4).

• Brand Name: AQUAMANTYS BIPOAR DISPOSABLE HAND PIECE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• MDR Report Key: 11412912
• MDR Text Key: 238373412
• Report Number: MW5099786
• Device Sequence Number: 1
• Product Code: GEI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/03/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR