MAUDE Adverse Event Report: GYRUS ACMI, INC. SLIMLINE SCOPE ADAPTOR; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Device Problems Fluid/Blood Leak (1250); Failure to Align (2522)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2022

Event Type  malfunction  

Event Description

Md attempting to perform hta (hydrothermal) ablation.The adaptor to the slimline scope leaking fluid.A total of 6 more trays opened to change out the adaptor and every adaptor was misaligned.Unable to realign rings/couplings; they were frozen in place.Family made aware that procedure was unable to be completed due to equipment failure.Patient was extubated and taken to pacu (post anesthesia care unit) without any issues.

• Brand Name: SLIMLINE SCOPE ADAPTOR
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• MDR Report Key: 15804413
• MDR Text Key: 303720837
• Report Number: 15804413
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/04/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/16/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 10585 DA
• Patient Sex: Female