MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF-RESECTION ELECTRODE, ROLLER, 24 - 28 FR.,; HF ELECTRODE

Model Number A22251C

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2016

Event Type  malfunction  

Manufacturer Narrative

The user facility returned two electrodes to olympus for evaluation.A visual inspection of the device referenced in this report confirmed that the loop was broken off and the roller ball was missing at the distal tip.There were burn stains on each posts of the electrode.The roller ball of the electrode was not returned for evaluation.Due to the received condition of the electrode no further testing could be performed.The most likely cause for the reported event can be attributed to the loop (ball) coming in contact with a metal or hard object during hf output, or excessive force being applied while moving tissue during the procedure.¿the instruction manual contains several caution statements in an effort to prevent damage to the electrode.¿when attaching the electrode, make sure not to push it too forcefully into the working element.When checking the locking of the electrode, make sure not to pull too forcefully.Otherwise the electrode may be damaged.Additionally, improper use of hf current can cause endogenous or exogenous burns, and explosions.Set the cutting current to 200w - 300w for vaporization.¿.

Event Description

Olympus was informed that during a therapeutic transurethral resection of the prostate (turp) procedure, the roller ball from the electrode broke off and fell into the patient.The device fragment was retrieved using forceps.It was reported a second electrode was used and the loop portion broke; however, the roller ball remained intact.There was no bleeding observed.The non olympus generator settings were coag 80/ cut 250.The intended procedure was completed with a third similar device.There was no patient injury reported.This is 1 of 2 reports.

• Brand Name: HF-RESECTION ELECTRODE, ROLLER, 24 - 28 FR.,
• Type of Device: HF ELECTRODE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 5992397
• MDR Text Key: 56108302
• Report Number: 2951238-2016-00773
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK903323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/30/2016

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 Model Number: A22251C
• Device Catalogue Number: A22251C
• Device Lot Number: 15329P02L002
• Other Device ID Number: 14042761036815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2016
• Initial Date FDA Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2015
• 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
• Treatment: VALLEY LAB GENERATOR