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

Model Number E2ROS-CF25

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 04/13/2015

Event Type  Injury  

Event Description

Olympus received a voluntary medwatch (b)(4) form that stated, "olympus turis resectoscope for transurethral resection of bladder tumor, tip of device came off inside pt's bladder and required removal of foreign body resulting in trauma to the urethra.Hospital involved will be contacted to obtain concomitant medical products and therapy dates.Hosp is (b)(6) 2015 hosp (b)(6).Dates of use: (b)(6) 2015.Used for turp and turbt." olympus followed up with the user facility and was informed that the reported incident occurred toward the end of a turbt procedure on (b)(6) 2015.The patient returned for a follow-up visit on (b)(6) 2015, to have the catheter removed as it was left in due to the trauma experienced from the foreign body removal.It was also reported that the foreign body was retrieved by holding the broken tip in the same orientation as its insertion during removal.No additional information has been provided.

Manufacturer Narrative

The device referenced in this report has not yet been returned to olympus for evaluation.The exact cause of the patient's outcome could not be conclusively determined at this time.If additional information becomes available at a later time, this report will be supplemented.

• Brand Name: RESECTOSCOPE, WORKING ELEMENT
• Type of Device: RESECTOSCOPE, WORKING ELEMENT
• Manufacturer (Section D): GYRUS ACMI INC.; 136 turnpike road; southborough MA 01772 210
• Manufacturer Contact: noemi schambach ; 2400 ringwood ave; san jose, CA 95131 ; 4089355002
• MDR Report Key: 4919009
• MDR Text Key: 20776638
• Report Number: 2951238-2015-00303
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K890328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E2ROS-CF25
• Device Catalogue Number: E2ROS-CF25
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2015
• Initial Date FDA Received: 07/16/2015
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 90