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

Model Number 880-213

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105); Device Inoperable (1663); Failure to Cut (2587)

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

Event Date 05/01/2015

Event Type  malfunction  

Event Description

Doctor was beginning a tur of bladder tumor and the resectoscope cutting loop was not working, it wasn't completely cutting through the tissue.The doctor took device out of bladder and found that the loop was broken.Doctor began again with second loop and had the same problem.The second time, however, the entire loop broke off and was later retrieved from the bladder.A third loop was opened but because of the patient's lack of muscle relaxation, doctor opted to complete the procedure using a cup biopsy forcep and bugby electrode.The manufacturer was contacted and a complaint reported.Cautery settings at the time were 180 pure cut, 85 coag.Our hospital's biomed tech took this machine out of service for evaluation.There was a similar situation with the resectoscope cutting loop in another case earlier in the week.Our hospital's biomed tech could not find anything out of the ordinary regarding the loops.Manufacturer boston scientific was notified of the issue with the loops.We have three photographs available pertaining to the incident if medsun would like to see those.

Manufacturer Narrative

Lot #0115006 ((b)(4)) received a returned product sample back for technical analysis on 05/18/2015.The returned product sample shows that extreme force was applied by the end user.Device #2, lot #0115006 ((b)(4)) received a returned product sample back for technical analysis on 05/18/2015.The returned product sample shows that extreme force was applied by the end user.However the actual complaint was not received by prosurg until 07/01/2015.Device#3, lot# 0115006 ((b)(4)) prosurg did not receive any product sample back for this complaint for technical analysis.The complaint states that the product was disposed of by the hospital.The loop has been validated to withstand a 3 lb pull force.It is the rf energy which is designed to resect the tissue not the mechanical force applied by the end user.Based on the description of the event and the responses from the hospital nurse suggest that the bladder tumor was possibly fibrous or calcified not to allow soft tissue resection.Nurse's response "the nurse mentioned that it had more to do with the patient than the loop.".

• Brand Name: SIGNATURE SERIES RF ELECTRODES
• 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: 4898485
• MDR Text Key: 6542543
• Report Number: 3006789154-2015-00001
• 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: Unknown
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/01/2015

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
• Device Expiration Date: 01/31/2018
• Device Model Number: 880-213
• Device Catalogue Number: M0068802131
• Device Lot Number: 0115006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/01/2015
• Event Location: Hospital
• Date Report to Manufacturer: 05/04/2015
• Initial Date Manufacturer Received: 05/04/2015
• Initial Date FDA Received: 07/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR