MAUDE Adverse Event Report: PROSURG, INC. SIGNATURE SERIES RF ELECTRODE; CUTTING LOOP

Model Number 880-203

Device Problem Flaked (1246)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2014

Event Type  Other  

Event Description

The urologist noticed that numbers off the scope were floating around the pt's bladder.The physician irrigated the bladder and numbers were successfully removed from the pt's bladder.The pt was noted to be fine and there were no complications noted after the procedure.

Manufacturer Narrative

Based on laboratory and microscopic examination of returned sample, we have determined that numbers were scraped off due to sharp edge of the resectoscope working element.

• Brand Name: SIGNATURE SERIES RF ELECTRODE
• Type of Device: CUTTING LOOP
• Manufacturer (Section D): PROSURG, INC.; san jose CA 95131
• Manufacturer Contact: 2195 trade zone blvd; san jose, CA 95131 ; 4089454040
• MDR Report Key: 4040132
• MDR Text Key: 4908624
• Report Number: 3006789154-2014-00001
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: 880-203
• Device Catalogue Number: M0068802031
• Device Lot Number: 0114018
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/28/2014
• Distributor Facility Aware Date: 05/12/2014
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/03/2014
• Date Manufacturer Received: 05/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 75