MAUDE Adverse Event Report: OLYMPUS OLYMPUS TURIS

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/13/2015

Event Type  malfunction  

Event Description

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) hosp (b)(6).Dates of use: (b)(6) 2015.Used for turp and turbt.

• Brand Name: OLYMPUS TURIS
• Type of Device: OLYMPUS TURIS
• Manufacturer (Section D): OLYMPUS; hamburg 2377 65; GM 237765
• MDR Report Key: 4707027
• MDR Text Key: 5662450
• Report Number: MW5042134
• Device Sequence Number: 1
• Product Code: FDC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/14/2015

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: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/14/2015
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 90