MAUDE Adverse Event Report: GYRUS ACMI, INC.; RESECTOSCOPE, WORKING ELEMENT

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/16/2023

Event Type  malfunction  

Event Description

[redacted name] or reports that patient was for a transuretheral resection of a bladder lesion.Shortly after the start of the procedure, a foreign object was noted on the display screen inside the bladder.Resectoscope was removed from patient and examined by surgeon/team.It was noted that a portion of the sheath had been damaged/chipped and was missing.Alternative instrumentation obtained to remove segment inside of patient.Case proceeded without further incident.

• Type of Device: RESECTOSCOPE, WORKING ELEMENT
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• MDR Report Key: 17215975
• MDR Text Key: 318026753
• Report Number: 17215975
• Device Sequence Number: 1
• Product Code: FDC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/16/2023

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: Other
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/16/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/28/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male