MAUDE Adverse Event Report: GYRUS ACMI INC OLYMPUS RESECTOSCOPE

Model Number CF27

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problems Obstruction/Occlusion (2422); Foreign Body In Patient (2687)

Event Date 09/18/2015

Event Type  malfunction  

Event Description

Patient was scheduled for greenlight laser prostatectomy for a bladder neck obstruction.At the completion of the procedure, it was observed that there were foreign bodies in the patient's bladder visible through the cystoscope.A grasping forcep was used to remove a piece of the resecting continuous flow sheath.No further foreign bodies were seen visually on the camera at the end of the procedure by the surgeon.Patient was unharmed and discharged the day of the procedure to go home.Black plastic piece at the tip of the resectoscope appears to have broken off.Piece was retained along with the resectoscope and sent to the manufacturer's representative for evaluation.Manufacturer response for continuous flow resecting instrument, olympus acmi resectoscope (per site reporter): manufacturer will investigate the equipment.Serial # is inside the scope and can't be seen by operator.

• Brand Name: OLYMPUS RESECTOSCOPE
• Type of Device: RESECTOSCOPE
• Manufacturer (Section D): GYRUS ACMI INC; 3500 corporate parkway; center valley parkway PA 18031
• MDR Report Key: 5235281
• MDR Text Key: 31575721
• Report Number: 5235281
• Device Sequence Number: 1
• Product Code: FJL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Model Number: CF27
• Other Device ID Number: E205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/13/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/13/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/19/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 83