MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH WORKING ELEMENT, PASSIVE, FOR TURIS

Model Number WA22367A

Device Problems Break (1069); Electrical Shorting (2926)

Patient Problem Electric Shock (2554)

Event Date 10/26/2016

Event Type  Injury  

Manufacturer Narrative

The device was returned to olympus for evaluation.A visual inspection was performed and found the working element had a stain inside the teflon body and cap with a sharp edge at distal tip of the electrode guiding tube.The device failed the electrical leakage test at the teflon body and failed the water leakage test at electrode seal (locking cone of the working element).The customer returned the electrode used during the procedure; however, due to the physical damage it could not be connected to the working element for the continuity testing.Based on the investigation findings, the root cause for the reported event can be attributed to the working element coming in contact with fluid or debris build up inside the actuator block while activating the foot pedal on the electro-surgical unit sending an electrical current through the high-frequency cable into the working element.The device will be sent to the oem for further investigation.The instruction manual warns users ¿when attaching the electrode to the working element, make sure that the electrode clicks into position audibly, and check the locking and position of the electrode as described below.If the electrode is not attached securely to the working element, spark discharge may occur and the instrument may be damaged.¿.

Event Description

Olympus was informed that during a transurethral resection of the prostate (turp) procedure, the patient was shocked due to the device arcing.It was reported that the surgeon noticed that the working element seal had broken and releasing fluid.The procedure was aborted due to the user facility not having a sterile working element available to complete the procedure.The patient was monitored and then discharged home the same day.This is 1 of 2 reports.

Manufacturer Narrative

This supplemental report is being supplemented to provide additional information based on the original equipment manufacturers (oem) evaluation.The oem¿s investigation is consistent with the customer¿s report, and the working element was manufactured in (b)(6) 2012.Visual inspection of the working element showed considerable signs of wear and tear like corrosion, dents, and scratches and worn inscription.The working element¿s electrode guiding tube on the distal end is heavily damaged.The gold-plated cone shows developed corrosion.Considerable signs of hf spark-over and corrosion are evident.The connection area between working element and hf cable shows considerable traces of arcing the working element passed the functionality check with following results: locking mechanism functions normally, the electrode clicks into position audibly.The locking mechanism of the electrode has no damages.The oem performed a leakage test with instrument combination of working element, telescope and the electrode passed without showing any abnormalities.The working element passed the electrical strength test.It was determined that the previously reported leakage of ¿fluid came out of the seal¿ was observed when the moisture leaked from the teflon body.However, the investigations verified the electrical resistance to be = 5¿ conforming to the specification.A visual inspection of customer¿s hf-resection oval button electrode model: (b)(4) was performed and found the insulation tube of the hf-resection electrode with more or less severe mechanical damage, especially the area affected by hf arcing.It was noted be considerably worn inscription of the hf-resection electrode and observed stress marks inside the telescope guiding tube indicate repeatedly use of the single use electrode.The distal end of hf-resection electrode was noted to be severely deformed.Thereby the insulation tube of the electrode got damaged to the extent of failed electrical strength.There was also evidence that during use, four short circuits occurred at least between the electrode and the working element.Based on the investigation findings, the root cause for charred stains and developed corrosion on the working element is traced back to the incorrect and/or insufficient reprocessing/drying as well as improper assembly of the hf-resection electrode leading to spark discharge and instrument damage.The risk associated with this damage was assessed as acceptable, when considering the hints and caution notes included in the instructions for use.The instruction manual warns users ¿make sure that the product has been properly reprocessed, inspected, and tested before use.Make sure that it has no corrosion, no dents, and no scratches.When attaching the electrode to the working element, make sure that the electrode clicks into position audibly, and check the locking mechanism and position of the electrode.If the electrode is not attached securely to the working element, spark discharge may occur and the instrument may be damaged.¿.

• Brand Name: WORKING ELEMENT, PASSIVE, FOR TURIS
• Type of Device: WORKING ELEMENT
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6115475
• MDR Text Key: 60415800
• Report Number: 2951238-2016-00872
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK030194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WA22367A
• Device Catalogue Number: WA22367A
• Device Lot Number: 123W
• Other Device ID Number: 04042761066242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: WA22566S HF-ELECTRODE/
• Patient Outcome(s): Other