MAUDE Adverse Event Report: GYRUS ACMI, INC ROTATING CF RESECTOSCOPE INNER SHEATH

Model Number ERIS-CF27

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2015

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not yet been returned to olympus for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information or the device is returned at a later time, this report will be supplemented.

Event Description

Olympus was informed that during a trans-urethral resection of a bladder tumor (turbt) procedure, the device broke off and fell inside the patient.The physician was unable to visualize the fragment in the bladder.It was reported that no x-ray was performed.It is believed that the fragment must have been irrigated out.The intended procedure was completed with another similar device.There was no patient injury reported.No additional information was provided.

• Brand Name: ROTATING CF RESECTOSCOPE INNER SHEATH
• Type of Device: RESECTOSCOPE INNER SHEATH
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772 2104
• Manufacturer Contact: donny shapiro ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355161
• MDR Report Key: 5336349
• MDR Text Key: 34758949
• Report Number: 2951238-2015-00634
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ERIS-CF27
• Device Catalogue Number: ERIS-CF27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1