MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OLYMPUS HF RESECTION ELECTRODES

Model Number A22206C

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2015

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not yet been returned to olympus for evaluation.The instruction manual warns users before use: "visually inspect the instrument.Warped electrodes, defective insulation and broken, cracked, or irregular cutting loops represent a danger for both the patient and the surgeon and must not be used." if additional information is received at a later time this report will be supplemented.Please cross reference mfr.Report number: 2951238-2015-00511.

Event Description

Olympus was informed that during a therapeutic transurethral resection of the prostate (turp) procedure, the loop cracked (broke) while cutting tissue.The physician used a second loop and again the loop wire cracked.It was reported that no device fragment fell into the patient.The intended procedure was completed with a third loop.There was no patient injury reported.A non-olympus generator was used during the procedure and the settings were cut/coag (200/120).No further information was provided.This is one of two reports.

• Brand Name: OLYMPUS HF RESECTION ELECTRODES
• Type of Device: RESECTION ELECTRODES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: noemi schambach ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355002
• MDR Report Key: 5182118
• MDR Text Key: 29403656
• Report Number: 2951238-2015-00510
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K903323
• 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
• Report Date: 10/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A22206C
• Device Catalogue Number: A22206C
• Device Lot Number: 15057P02L001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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