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

Model Number ERIS-CF27

Device Problems Break (1069); Component Falling (1105)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/06/2014

Event Type  malfunction  

Event Description

Male patient with a benign prostatic hypertrophy with obstruction and urinary retention underwent a transurethral resection of the prostate with gyrus.A 27 french resectoscope was placed into the bladder and resection of the prostate was done.Intially, the median lobe was resected.Next, resection was done from the bladder neck all the way back to the verumontanum in a circumferential manner.Once full resection was performed.There appeared to be no significant obstructing tissue.Near the end of the procedure the plastic tip on the end of the sheath broke into two pieces.The larger piece dropped off into the patient's bladder.The smaller piece stayed intact on the end of the sheath.Using a grasper, the physician was able to remove the piece from the bladder.Electrocautery was then used for control of any areas of bleeding and hemostasis was ensured.The patient tolerated the procedure well and was taken to recovery in stable condition.

• Brand Name: GYRUS ACMI
• Type of Device: RESECTOSCOPE, SHEATH
• Manufacturer (Section D): GYRUS ACMI, INC.; 136 turnpike road; southborough MA 01772
• MDR Report Key: 3893486
• MDR Text Key: 4540447
• Report Number: 3893486
• Device Sequence Number: 1
• Product Code: FDC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/30/2014

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: Physician
• Device Model Number: ERIS-CF27
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/30/2014
• Event Location: Hospital
• Date Report to Manufacturer: 06/25/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/30/2014
• Patient Sequence Number: 1
• Patient Age: 59 YR