MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE "PLASMALOOP", LOOP; HF RESECTION ELECTRODE

Model Number WA22703S

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2019

Event Type  malfunction  

Manufacturer Narrative

The user facility returned the used device (including hf cable) to the service center for evaluation.The user facility also returned three brand new brand new devices.The electrode loop has no charred debris, but the two posts at the distal end and loop were severely bent as signs of use; there was no missing fragment noted.The insulation, and shaft are in good condition.A visual inspection of the corresponding hf cable found no abnormalities on the appearance.The electrode and its cable were checked together with our test working element, and the esg-400 with the default settings saline cut 200/ saline coag 120.Noted the electrode would cut, or coag a tissue sample which was submerged in the 0.9%saline solution without a delayed firing.No intermittent problem was observed.A review of the device history records was conducted as the manufacturing and quality control review was performed for the affected lot number without showing any non-conformities or deviations regarding the described issue.Based on the evaluation findings, the cause of reported event could not be determined as both the used and new devices worked appropriately when tested with manufacturer test equipment.However, the most probable cause of the bent loop and insulated posts at the distal end of the device are attributed to excessive overload from force/stress applied to the device.The device instruction manual indicates, to ensure only saline is used as the irrigant, and ensure both cable connections at the olympus resectoscope are secure.¿ if necessary, adjust the settings to the procedure and the required tissue effects.Increase the output power to a level that is needed for sufficient resection.If non-conductive irrigation fluids are used, there will be no cutting, coagulation or vaporization effect.¿ when using the resectoscope in combination with the electrosurgical generator plasmakinetic¿ superpulse or esg- 400, only use normal saline.

Event Description

The manufacturer was informed that at the beginning of a transurethral resection of the prostate procedure, the customer was having a hard time firing the loop as the loop was sputtering and at times unresponsive.A second electrode loop was used but the same problem persisted.There was no breakage or sparking/arcing to the loops reported.Then tried to replace the generator but the same issue occurred.The generator settings were set to default 200watts (cut)-120watts (coag).The user reported there was no errors observed and that the generator did not malfunction as the user determined the problem was with the loop as once the user opened a different (medium) loop it worked and the procedure was completed.There was a 30-40 minute delay in the procedure.There was no serious injury or death reported.The electrode and connections to the working element were inspected prior to use, there were no anomalies noted.This is for 2 of 2 reports.

• Brand Name: HF-RESECTION ELECTRODE "PLASMALOOP", LOOP
• Type of Device: HF RESECTION ELECTRODE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662
• MDR Report Key: 9330310
• MDR Text Key: 198324804
• Report Number: 9610773-2019-00162
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 14042761085332
• UDI-Public: 14042761085332
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171965
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22703S
• Device Lot Number: 1000035477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1