MAUDE Adverse Event Report: PROSURG INC SIGNATURE SERIES RF ELECTRODES; RF CUTTING LOOP

Model Number 880-204

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/29/2015

Event Type  malfunction  

Manufacturer Narrative

The rf cutting loop electrode is assembled by inserting the proximal end in to the working element of resectoscope.Thereafter, the inner and outer metallic sheath is assembled, covering the rf electrode stem and distal tip.Upon application of rf energy via resectoscope connection, the cutting loop tip is energized for tissue resection.It is important that doctor activate the rf energy while the cutting loop tip is outside of the outer sheath and does activate rf energy inside the outer sheath.If for any reason the cutting loop tip comes in the contact with metallic viewing endoscope or metallic portion of the outer sheath (due to broken or missing ceramic insulation), while the rf energy is activated, resulting into short circuit and spark, causing loop wire to break.We would also live to point out that the event description states that the cutting loop broke and was attached to the (metallic) viewing endoscope, indicating potential direct contact and rf energy short circuit / spark between cutting loop and endoscope.It is also possible if the doctor used incorrect size of inner / outer sheath and cutting loop, causing loop to break.Since we did not receive info regarding instrumentation used during the procedure, it is difficult to conduct technical analysis and eval.

Event Description

The resection loop was inserted into the resectoscope, and then the scope was inserted into the urethra.The doctor activated the cutting energy, and almost immediately the stem of the resection loop broke at the distal end where it attaches to the scope.The distal tip was unable to be removed from the scope and the scope had to be sent out for repair.The procedure was eventually finished with a different scope and resection loop from another supplier.Event description update by (b)(6) on (b)(6) 2015 no harm to patient.(b)(4).

• Brand Name: SIGNATURE SERIES RF ELECTRODES
• Type of Device: RF CUTTING LOOP
• Manufacturer (Section D): PROSURG INC; san jose CA
• Manufacturer Contact: 2193 trade zone blvd; san jose, CA 95131 ; 4089454044
• MDR Report Key: 5357191
• MDR Text Key: 35999380
• Report Number: 3006789154-2015-00002
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/22/2015

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 Expiration Date: 02/28/2018
• Device Model Number: 880-204
• Device Catalogue Number: M0068802041
• Device Lot Number: 0215003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/11/2015
• Distributor Facility Aware Date: 11/04/2015
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/02/2015
• Date Manufacturer Received: 12/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR